Single-Use NPWT Devices: FDA Registration, CMS Coding & the Disposable Shift

A comprehensive guide to single-use negative pressure wound therapy (sNPWT) systems, covering FDA product codes, CPT/HCPCS reimbursement, and business strategies.

The Shift from Durable Carts to Pocket-Sized Consumables

For decades, negative pressure wound therapy (NPWT) was defined by heavy, durable pumps on wheeled carts, large fluid canisters, and complex bedside setups. These systems, while clinically effective for high-exudate wounds, imposed significant capital costs, intensive sterilization and logistics, and severe mobility limitations on patients. Today, the wound care industry is experiencing a profound transition toward single-use (disposable) negative pressure wound therapy (sNPWT or ciNPWT) systems. These pocket-sized, canister-less devices operate on mechanical or light battery power, applying negative pressure directly through multi-layered dressings that manage exudate via evaporation and absorption.

For medical device manufacturers, distributors, and healthcare technology management (HTM) teams, entering or navigating the single-use NPWT space requires an understanding of how regulatory classification, clinical safety, and reimbursement mechanics intersect. The shift is not merely clinical; it represents a fundamental business model restructuring from capital leasing to recurring consumable sales. This guide provides a detailed breakdown of FDA registration requirements, CMS CPT and HCPCS coding, Medicare coverage policies, and the strategic commercial dynamics driving the disposable NPWT market.

FDA Regulatory Pathway and Product Codes

Single-use NPWT systems are regulated by the FDA as Class II medical devices. To market a new system in the United States, manufacturers must secure clearance via the 510(k) submission process, demonstrating substantial equivalence to an existing cleared predicate device.

The FDA classifies these systems under two primary product codes depending on their design, intended use, and whether they are cleared for open wounds or closed surgical incisions.

1. Product Code OMP (Powered Suction Pump)

Under 21 CFR 878.4780 (Powered Suction Pump), the FDA regulates powered negative pressure wound therapy systems. Devices cleared under this code are indicated for a wide range of wound types, including chronic, acute, traumatic, subacute, and dehisced wounds, as well as partial-thickness burns, ulcers (diabetic, pressure, and venous insufficiency), and flaps or grafts.

Predicates & Clearances:
- Smith & Nephew PICO 7 Single-Use NPWT System: Cleared under multiple 510(k)s, including K203716, K211318 (decision date January 5, 2022), and K202157 (received August 3, 2020). These clearances establish the PICO system as a primary predicate for canister-less, pocket-sized sNPWT.
- ConvaTec Avelle sNPWT System: Cleared under K180205, utilizing a hydrofiber-infused dressing coupled with a small electronic pump.

2. Product Code QFC — NPWT Device for Reduction of Wound Complications (21 CFR 878.4783)

For devices indicated to reduce wound complications on closed surgical incisions, the FDA uses a separate, newer classification: 21 CFR 878.4783, product code QFC ("Negative Pressure Wound Therapy Device for Reduction of Wound Complications"). This regulation was created in 2019 through a De Novo classification (DEN180013) after the FDA determined that "reduction of wound complications" (e.g., lower surgical site infection and seroma rates in high-risk patients) was a distinct intended use from general wound management. These devices are still powered suction pumps, but they are intended for use with wound dressings classified under 878.4780, and they exclude organ-space wounds.

Predicates & Clearances:
- Solventum (formerly 3M/KCI) Prevena Plus 125 Therapy Unit: Cleared under K223263 (decision date February 13, 2023; product codes QFC and OMP), building on the original De Novo grant (DEN180013) for the Prevena 125 and Prevena Plus 125 Therapy Units. The Prevena system is widely recognized as the market pioneer for closed-incision applications, utilizing custom-shaped foam dressings designed specifically for linear or surgical wounds.

3. Non-Powered NPWT — Product Code OKO (21 CFR 878.4683)

Not every single-use NPWT system uses a battery or motor. Mechanical, non-powered systems are classified under a different regulation from the powered pumps above: 21 CFR 878.4683, product code OKO ("Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy"). The FDA's non-powered NPWT special-controls guidance explicitly excludes powered pumps (OMP/878.4780) from this code. Manufacturers choosing a mechanical architecture are therefore working under a separate 510(k) predicate set, not under OMP.

Predicates & Clearances:
- Spiracur SNaP Wound Care System: Originally cleared under K081406 in 2009 under 878.4683 / product code OKO. The SNaP system uses a spring-activated mechanism rather than a battery-powered motor to generate negative pressure (typically calibrated to −125 mmHg), demonstrating that single-use NPWT does not require a powered suction pump — but only because it is classified under a dedicated non-powered regulation, not under OMP.

Regulatory Classification Reference Table

FDA Product Code	Regulation (21 CFR)	Device Description	Classification	Common Predicates / Clearances	Typical Clinical Indications
OMP	878.4780	Negative Pressure Wound Therapy Powered Suction Pump	Class II (510(k))	Smith & Nephew PICO 7 (K211318, K202157), ConvaTec Avelle (K180205)	Chronic ulcers, acute/traumatic wounds, dehisced surgical wounds, pressure injuries, flaps/grafts.
QFC	878.4783	NPWT Device for Reduction of Wound Complications (powered, closed-incision)	Class II (510(k); De Novo DEN180013)	Solventum Prevena Plus 125 (K223263)	Class I and Class II closed surgical incisions in high-risk patients — reduce SSI and seroma.
OKO	878.4683	Non-Powered Suction Apparatus Device Intended for NPWT	Class II (510(k))	Spiracur SNaP Wound Care System (K081406)	Low-exudate chronic, acute, and dehisced wounds; surgically closed incisions (non-powered).

When structuring a regulatory dossier, manufacturers must evaluate whether their device's pump and dressing configuration aligns with the 510(k) submission process guidelines. Specifically, the choice of predicate determines the testing standards required, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and extensive bench testing to demonstrate consistent negative pressure maintenance under simulated fluid flow.

Technical Distinctions: Powered vs. Mechanical (Non-Powered) Systems

Within the single-use NPWT landscape, devices diverge significantly in their engineering design. Manufacturers must choose between powered electronic designs and mechanical, non-powered suction systems. Each design impacts the regulatory testing dossier and the clinical setting.

Powered (Electronic) sNPWT Systems

Systems such as Smith & Nephew's PICO and Solventum's Prevena rely on small, battery-operated electric pumps.

Engineering Design: These systems utilize micro-diaphragm pumps driven by DC motors, regulated by pressure sensors and simple microcontrollers. The electronic controls allow the device to run diagnostic checks, regulate negative pressure dynamically (usually maintaining a target of -80 mmHg to -125 mmHg), and alert users to dressing leaks, blockage, or low battery status.
Testing Burden: Under the FDA 510(k) pathway, electronic systems require compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). Software verification and validation are required under the FDA's software guidance, alongside battery safety testing (such as IEC 62133).
Clinical Advantage: The active controls ensure that negative pressure is maintained even in the presence of minor dressing leaks, as the pump can dynamically adjust its duty cycle.

Mechanical (Non-Powered) sNPWT Systems

Mechanical systems, pioneered by the Spiracur SNaP device, generate suction using purely mechanical forces. Because they contain no powered suction pump, they are classified under a separate FDA regulation — 21 CFR 878.4683, product code OKO ("Non-Powered Suction Apparatus Device Intended for NPWT") — rather than under the powered-pump code OMP. The choice between a powered (OMP/QFC) and a non-powered (OKO) architecture therefore changes both the applicable 510(k) predicate and the testing dossier.

Engineering Design: The SNaP system utilizes a constant force spring mechanism coupled with a flexible diaphragm. When the device is primed by compressing the spring, the spring exerts a constant tension, drawing the diaphragm back and creating a stable vacuum (typically calibrated to -125 mmHg).
Testing Burden: Because there are no electrical components, mechanical systems bypass IEC 60601 electrical and software testing, reducing the 510(k) testing burden and lowering manufacturing costs. The validation focus shifts entirely to mechanical cycle fatigue testing, spring rate stability over time, and leak rate resistance.
Clinical Advantage: Completely silent operation, zero battery disposal concerns, and simplified user operation. However, because there are no electronic sensors, mechanical systems cannot alert patients to a leak or blockage via an audible alarm; instead, they rely on visual indicators (such as the collapse of a vacuum indicator on the dressing or pump).

CMS Coding & Reimbursement Mechanics

The commercial viability of a single-use NPWT system depends on its reimbursement status. In the United States, the Centers for Medicare & Medicaid Services (CMS) differentiates between durable (reusable) NPWT pumps and single-use (disposable) systems. Understanding this distinction is critical for device developers who must align their product design and marketing with CMS billing rules.

CPT Coding for Disposable NPWT

Unlike durable NPWT, which is billed using separate codes for the pump rental, canister, and dressing kits, single-use NPWT is billed as a bundled service. The American Medical Association (AMA) CPT code set defines two codes for the application and management of disposable NPWT, which include the device itself, all necessary dressings, and the professional clinician's time to apply the system:

CPT 97607: Debridement active wound care/receptacle; negative pressure wound therapy, (e.g., disposable 1-time use system), includes provision of disposable system, application, and instructions for use; total wound(s) surface area less than or equal to 50 square centimeters.
CPT 97608: Negative pressure wound therapy, (e.g., disposable 1-time use system), includes provision of disposable system, application, and instructions for use; total wound(s) surface area greater than 50 square centimeters.

These codes are billed per care episode session by qualified healthcare professionals (physicians, physical therapists, wound care nurses) in settings such as physician offices or outpatient clinics.

Durable vs. Disposable NPWT Coding Structure

Coding/Billing Attribute	Disposable NPWT (sNPWT)	Durable NPWT (dNPWT)
Primary CPT Codes	CPT 97607 (≤ 50 sq cm) CPT 97608 (> 50 sq cm)	CPT 97605 (≤ 50 sq cm) CPT 97606 (> 50 sq cm)
HCPCS Supply Codes	None (Bundled into CPT 97607/97608)	HCPCS A6550 (Dressing kit, per kit) HCPCS A7000 (Canister, per canister)
DME Pump Rental Billing	Not Applicable (No rental fee)	HCPCS E2402 (Monthly pump rental)
Home Care Billing Status	HCPCS A9272 (Non-covered DME, unless billed via HHA)	HCPCS E2402 covered under DME benefit (if criteria met)
CMS Status Indicator (OPPS)	Status T (Multiple procedure reduction applies)	Status S (Significant procedure, no reduction)
APC Grouping	APC 5052 (Level II Debridement/Destruction)	APC 5051 (Level I Debridement/Destruction)

[!NOTE] Coding figures are current as of July 2026. CMS revises CPT/HCPCS descriptors, Ambulatory Payment Classification (APC) assignments, and status indicators annually through the OPPS and Physician Fee Schedule rulemaking, so the APC/status-indicator cells above should be re-verified against the current CMS fee schedule before use in a billing workflow.

Setting Dichotomy: Outpatient Clinic vs. Home Health vs. Skilled Nursing (SNF)

Reimbursement for single-use NPWT is highly setting-dependent, requiring distinct billing approaches for different sites of care:

Physician Office or Outpatient Clinic (PFS/OPPS): Under the Hospital Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS), the provider bills CPT 97607/97608. Under OPPS, these codes are assigned to APC 5052 (Level II Debridement/Destruction) with a Status Indicator T (Significant Procedure, subject to multiple procedure payment reduction). Under this arrangement, the cost of the disposable device is bundled into the facility payment. The hospital or clinic purchases the sNPWT kit directly, and the CMS reimbursement covers both the clinical labor and the equipment cost.
Home Health Agency (HHA) Plan of Care: If a patient is receiving home health services under a Medicare home health plan of care, the sNPWT device is subject to Consolidated Billing. The HHA must bill CPT 97607/97608. The cost of the single-use kit is not paid separately under Part B DME; instead, the HHA is paid for the clinical visit, and the cost of the sNPWT device is factored into the HHA's overall episodic payment.
Skilled Nursing Facility (SNF) Consolidated Billing: For patients in a covered Part A SNF stay, sNPWT is bundled into the SNF's Patient-Driven Payment Model (PDPM) rate. The SNF is responsible for providing the device, and separate billing under Part B is prohibited. For patients in a Part B SNF stay (not under a Part A covered stay), the SNF can bill CPT 97607/97608, receiving payment under the Physician Fee Schedule.

The Home-Use DME Denial Trap: HCPCS A9272

For durable NPWT, when a patient uses the pump in their home, the pump is billed under HCPCS code E2402 and paid under the Durable Medical Equipment (DME) benefit. However, single-use NPWT devices do not fit the statutory Medicare definition of "Durable Medical Equipment" because they are not designed for repeated use and are disposed of after the treatment course (typically 7 to 14 days).

To address single-use systems in the home, CMS established HCPCS code A9272 (Wound suction, disposable, includes dressing, all accessories and components, any type, each). Under Medicare Local Coverage Articles (such as LCA A52511) and Local Coverage Determinations (LCD L33821), HCPCS code A9272 is classified as non-covered under the DME benefit category.

This means that if a physician prescribes a single-use NPWT system for a patient to use at home, and the patient is not under an active Home Health Agency (HHA) plan of care, Medicare will not pay for the device under the DME benefit. This creates a significant coverage gap:

Office/Clinic Billing: Billed via CPT 97607/97608; covered as part of outpatient care.
HHA Billing: Covered under home health consolidated billing.
Independent Home Use (Without HHA): Billed under HCPCS A9272; denied by Medicare DME. Patients must pay out-of-pocket, or providers must seek commercial insurance pre-authorization.

Device manufacturers must navigate this setting dichotomy carefully. If a sales team markets a single-use device for "home use" without educating clinicians on the DME exclusion of HCPCS A9272, clinics will face clawbacks and denied claims. This policy context must be considered alongside broader CMS coverage pathways for devices and established Medicare device payment policy structures.

Evaporative & Absorptive Dressing Mechanisms: Canister-Less Technology

The core engineering breakthrough that enabled the transition to pocket-sized, single-use NPWT is canister-less dressing technology. In traditional NPWT, a vacuum pump draws wound exudate through tubing into a rigid plastic canister (usually 300ml to 1000ml). Canister-less systems manage exudate entirely within a multi-layered, specialized dressing, eliminating the need for a separate fluid collection vessel.

The Multi-Layer Dressing Architecture

A typical sNPWT dressing (such as those used in the PICO system) consists of several distinct layers designed to manage fluid while maintaining consistent negative pressure:

Silicone Wound Contact Layer: This layer lies directly against the wound bed or incision line. It features a perforated silicone adhesive design that allows fluid to pass through easily while preventing the dressing from adhering to the wound tissue. This minimizes pain and tissue damage during dressing changes.
Superabsorbent Co-Polymer Core: This layer contains superabsorbent polyacrylate polymers (SAPs). When wound exudate passes through the silicone layer, the SAPs lock the fluid into a gel matrix, keeping it away from the wound bed to prevent maceration of the surrounding skin.
High-MVTR Backing Film: The outermost layer is a polyurethane film with a high Moisture Vapor Transmission Rate (MVTR). This film allows moisture from the absorbed exudate to evaporate through the top of the dressing into the air, while remaining a barrier to liquid water, bacteria, and viral contaminants from the outside.

Evaporation Thermodynamics and Capacity Limits

By combining absorption and evaporation, a canister-less dressing can manage much more fluid than its physical thickness suggests:

Evaporative Capacity: Up to 80% of the fluid drawn into the dressing is evaporated through the high-MVTR backing film over a typical 7-day wear cycle. This allows a relatively thin dressing to manage several hundred milliliters of exudate without leaking.
Saturating Limits: Despite high MVTR, canister-less dressings have limits. In high-exudate wounds, the fluid volume can exceed the evaporative rate, saturating the superabsorbent core. Once saturated, the dressing blocks the transmission of negative pressure from the pump to the wound bed, triggering a dressing leak or blockage alarm. In such cases, clinicians must change the dressing more frequently, increasing treatment costs. For high-exudate wounds, durable NPWT with a fluid canister remains the clinically indicated choice.

FDA Safety and Labeling Requirements

While NPWT is a highly effective clinical tool, it carries serious safety risks that have been the subject of regulatory enforcement and public health alerts. Any manufacturer seeking to clear or distribute a single-use NPWT system must design their device labeling, instructions for use (IFU), and user training to address these risks.

The FDA Safety Communications (2009–2011)

In November 2009, the FDA issued a safety communication alerting healthcare providers to serious complications associated with negative pressure wound therapy systems. The FDA followed this with an updated safety communication in February 2011, titled "UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems."

The FDA's safety communications were based on analyses of adverse events reported to the Manufacturer and User Facility Device Experience (MAUDE) database. Key findings from this post-market surveillance data included:

Adverse Event Categories: The majority of reported events involved severe bleeding, worsening infections, and retained dressing materials (such as foam or gauze fragments) in the wound bed.
Fatalities: The FDA received reports of deaths associated with NPWT, primarily caused by massive hemorrhage when dressings were applied over exposed blood vessels, organs, or synthetic grafts.
Retained Dressing Material: Foam or gauze sticking to tissue led to secondary damage during dressing changes, or retained fragments served as a nidus for deep wound infections.

[!IMPORTANT] Understanding MAUDE Data Limits: In accordance with FDA guidelines, MAUDE database records represent passive surveillance report counts only. They do not represent clinical incidence rates, nor do they establish direct clinical causation. Because the denominator (total number of devices used) is unknown, and reporting is voluntary, these counts cannot be used to calculate risk or compare the safety profiles of different brands.

Labeling and Countermeasures for Single-Use Systems

To mitigate these risks and secure 510(k) clearance, single-use NPWT manufacturers must incorporate specific warnings, contraindications, and design features:

Contraindications: Labeling must clearly state that sNPWT is contraindicated for exposed vital structures (blood vessels, nerves, organs), untreated osteomyelitis, non-enteric and unexplored fistulas, necrotic tissue with eschar, and malignancy in the wound.
Bleeding Warnings: Users must be instructed to monitor patients for active bleeding, particularly those on anticoagulant therapy or with friable blood vessels.
Retained Foam/Dressing Documentation: Clinicians must document the exact number of dressing pieces placed in a wound. Many sNPWT dressing kits use specialized silicone layers rather than foam to reduce tissue adhesion and minimize the risk of retained material.
Alarms and Alerts: Unlike durable pumps with complex sensor arrays, single-use pumps must rely on simplified, cost-effective indicators (mechanical indicators or simple LED/buzzer circuits) to signal low vacuum, battery depletion, or dressing leaks.

Why the Disposable Kit is the Strategic Prize

The shift from durable to disposable NPWT is fundamentally remaking the economics of the wound care market. In the traditional durable model, manufacturers operated like heavy equipment providers: they maintained a large fleet of reusable pumps, managed regional depot networks for cleaning, sterilization, and repair, and relied on local sales reps to negotiate complex hospital rental agreements. This model was characterized by high capital expenditures, intense logistics, and high customer support costs.

The Razor and Razor-Blade Economic Model

Single-use NPWT shifts the business model to a classic "razor and razor-blade" strategy. The small, low-cost electronic or mechanical pump is packaged directly with the disposable dressing kits. The entire system is sold as a single unit or kit.

Elimination of Logistics Overhead: By selling the pump as a consumable, manufacturers eliminate the need for depot repair networks, decontamination facilities, and complex rental tracking software.
Recurring Revenue Streams: Once a clinic adopts a specific sNPWT brand, they must continue to purchase that brand's proprietary dressing kits for every new patient episode. The registered disposable kit becomes the high-margin, recurring asset.
Lower Entry Barrier for Distributors: Distributors who could not afford to build a durable pump rental infrastructure can easily stock and ship single-use kits.

As discussed in VEMERIX's disposable NPWT market shift report, this economic restructuring is the primary driver behind major medtech acquisitions and product development cycles. The company that secures FDA clearance and CMS coding for a lower-cost, highly reliable single-use kit can capture market share rapidly by bypassing the traditional hospital purchasing bottlenecks associated with capital leasing.

Multi-Region Registration Considerations

For manufacturers planning a global launch, the transition to sNPWT alters the registration cost profile. While registering a durable pump in the European Union or Asia requires compliance with electrical safety and software validation standards, registering the single-use system requires managing the sterilization validation (usually Gamma or Ethylene Oxide) of the combined dressing-pump kit.

Understanding the device registration cost and regulatory timelines across target regions is essential to synchronize US FDA clearance with EU MDR CE marking.

Durable vs. Disposable: Clinical & Operational Decision Matrix

To assist healthcare facilities, procurement committees, and clinical teams in evaluating NPWT options, the following matrix outlines the decision rules for choosing between durable and single-use systems:

Decision Factor	Reusable / Durable NPWT (dNPWT)	Single-Use / Disposable NPWT (sNPWT)
Primary Clinical Indication	High-exudate wounds, deep cavities, large surgical dehiscence.	Low-to-moderate exudate wounds, shallow ulcers, closed incisions.
Wound Size Limits	Virtually unlimited (restricted only by dressing coverage).	Generally limited to wounds ≤ 50 sq cm (CPT 97607) or up to 100 sq cm.
Exudate Management	High capacity (300ml to 1000ml canister volumes).	Low capacity (canister-less; moisture vapor transmission and absorption).
Patient Mobility	Restricted (heavy device, requires power cord or frequent charging).	High (pocket-sized, light, can be worn under clothing).
Care Setting Suitability	Acute care (hospital), skilled nursing facility, managed home care.	Outpatient clinic, physician office, active home health care.
Asset Management & Cleaning	Requires tracking, sterilization, preventative maintenance, depot repair.	Zero operational overhead (single patient use, dispose after use).
Total Care Episode Cost	High for short durations (due to pump rental fees); cost-effective for >30 days.	Low for short durations (7–14 days); high if multiple kits are used over >30 days.

Frequently Asked Questions

Is single-use NPWT covered by Medicare in the home?

Single-use NPWT is not covered under the Medicare Durable Medical Equipment (DME) benefit when billed using HCPCS code A9272. Because sNPWT devices are disposable and single-use, they do not meet the statutory definition of DME.

However, sNPWT is covered in the home if the patient is under an active Home Health Agency (HHA) plan of care. In this scenario, the HHA bills CPT code 97607 or 97608, and the device cost is bundled into the agency's prospective payment system rate.

What FDA product code is used for PICO, Prevena, and Avelle single-use NPWT?

The Smith & Nephew PICO and ConvaTec Avelle systems are cleared under FDA product code OMP (Powered Suction Pump, regulated under 21 CFR 878.4780).

The Solventum Prevena system, when indicated specifically for closed surgical incisions to reduce surgical site complications, is regulated under product code QFC / 21 CFR 878.4783 ("Negative Pressure Wound Therapy Device for Reduction of Wound Complications"). Mechanical, non-powered systems such as the Spiracur SNaP fall under a third code: product code OKO / 21 CFR 878.4683 ("Non-Powered Suction Apparatus Device Intended for NPWT").

What CPT codes bill disposable vs. durable NPWT?

Disposable NPWT: Billed using CPT 97607 (wounds ≤ 50 sq cm) or CPT 97608 (wounds > 50 sq cm). These codes are bundled and include the provision of the disposable device and dressings.
Durable NPWT: Billed using CPT 97605 (wounds ≤ 50 sq cm) or CPT 97606 (wounds > 50 sq cm). The clinician bills separately for the professional service, while the durable pump rental is billed under HCPCS E2402, and supplies are billed under HCPCS A6550 (dressing kit) and A7000 (canister).

Sources

FDA 510(k) Database: Smith & Nephew PICO 7 Single-Use NPWT System, Clearance Records K211318 and K202157.
Centers for Medicare & Medicaid Services (CMS): Billing and Payment Policies for Negative Pressure Wound Therapy Using a Disposable Device, Medicare Learning Network (MLN) Matters, Article SE17027.
FDA Safety Communication: Serious Complications Associated with Negative Pressure Wound Therapy Systems (2009, Updated 2011), FDA Center for Devices and Radiological Health. FDA Safety Communication Link.
CMS Medicare Coverage Database: Billing and Coding: Negative Pressure Wound Therapy (NPWT), Local Coverage Article A53781.
Industry Analysis: VEMERIX, From the Pump Cart to the Pocket: The Disposable Shift in Negative-Pressure Wound Therapy (Jul 2026), VEMERIX NPWT market handoff report.
FDA Product Classification & De Novo Records: Product code OMP / 21 CFR 878.4780; product code QFC / 21 CFR 878.4783, established via De Novo DEN180013 (Prevena 125 and Prevena Plus 125 Therapy Units), with the Prevena Plus 125 subsequent clearance K223263; and ConvaTec Avelle clearance K180205.
FDA Guidance: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) — Class II Special Controls Guidance (product code OKO / 21 CFR 878.4683), and Spiracur SNaP clearance K081406. FDA Non-Powered NPWT Guidance.