ResMed Global Regulatory Footprint: AirSense 11, Smart Comfort AI, and Market Access

Executive Summary

What does ResMed's medical-device regulatory footprint look like, including the FDA 510(k) clearance history of AirSense, AirCurve, Astral, and Smart Comfort, the applicable product codes, and worldwide sleep-apnea market access?

ResMed (NYSE/ASX: RMD) is the global leader in sleep and respiratory care, with an FDA clearance genealogy built on three product-code families: the AirSense CPAP/APAP and AirCurve bilevel/ASV devices under product code BZD (21 CFR 868.5905, Non-continuous ventilator/IPPB, Class II; AirSense 11 = K203126; AirCurve 10 ASV = K160822); the Astral 100/150 life-support ventilators under product code CBK with secondary code NOU (21 CFR 868.5895, Continuous Ventilator, Facility Use, Class II; K133868, K152068, K172875); and a growing software/AI layer including the myAir companion app (K241216), EasyCare Tx 2 (K241939), and Smart Comfort. On December 8, 2025, ResMed announced the FDA 510(k) clearance of Smart Comfort (submitted as Personalized Therapy Comfort Settings, PTCS), the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings for CPAP therapy. Trained on more than 100 million nights of de-identified real-world sleep data, Smart Comfort will launch in a limited US beta in early 2026 on the AirSense 11. Globally, ResMed has captured the largest share of the obstructive sleep apnea (OSA) treatment market, estimated at 50-60%, following Philips' PE-PUR foam recall and subsequent US consent-decree market exit.

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What FDA Product Codes and Classification Regulations Govern ResMed's Core Portfolio?

Analyzing ResMed's regulatory portfolio requires understanding the distinction between continuous (life-support) ventilation and non-continuous (sleep-apnea therapy) ventilation. The FDA maintains a clear line of demarcation between these categories, assigning distinct product codes, classification regulations, and special controls to each.

1. Product Code BZD: Non-Continuous Ventilator (IPPB)

This classification governs ResMed's sleep-apnea machines, including the AirSense and AirCurve series.

• Regulation Number: 21 CFR 868.5905
• Classification: Class II (Performance Standards)
• Description: A device intended to deliver inspiratory flow to a patient to assist ventilation or supply positive airway pressure. It is designated as "non-continuous" because it is not intended to provide life-support ventilation.
• Associated Devices: AirSense 10/11 AutoSet, AirSense 10/11 Elite, AirCurve 10/11 VAuto, AirCurve 10 ASV, and S9 series.

2. Product Code CBK & NOU: Continuous Ventilator

This classification governs ResMed's life-support and home mechanical ventilators.

• Regulation Number: 21 CFR 868.5895
• Classification: Class II (Special Controls)
• Description: A device intended to continuously assist or control patient ventilation. It is a life-support device designed to operate for extended periods under rigorous reliability standards.
• Product Code CBK: Continuous ventilator (facility use).
• Product Code NOU: Continuous ventilator (home use).
• Associated Devices: Astral 100, Astral 150, Stellar 150, and Elisée series.

3. Classification Differences and Regulatory Scrutiny

Devices registered under continuous ventilation (21 CFR 868.5895) undergo much tighter regulatory scrutiny than those under non-continuous ventilation (21 CFR 868.5905). The premarket notification [510(k)] submissions for continuous ventilators require extensive verification of software reliability (Major Level of Concern under previous guidelines, or High Documentation Level under modern FDA software guidances), electrical safety under IEC 60601-1, and battery backup systems. BZD devices, while still Class II, generally require a Moderate Documentation Level for software and focus heavily on biocompatibility, gas pathway toxicity, and electromagnetic compatibility (EMC) in home environments.

Device Family	Primary FDA Product Code	Regulation Number	FDA Classification	Intended Use / Patient Population
AirSense 10 / 11	BZD	21 CFR 868.5905	Class II	Treatment of Obstructive Sleep Apnea (OSA) in patients weighing >30 kg (>66 lbs).
AirCurve 10 / 11 (bilevel/ASV)	BZD	21 CFR 868.5905	Class II	Treatment of OSA, Central Sleep Apnea (CSA), or mixed apnea. ASV is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced LVEF ($\le 45%$).
Astral 100 / 150	CBK (Primary), NOU (Secondary)	21 CFR 868.5895	Class II	Continuous or intermittent mechanical ventilation for patients weighing >5 kg (>11 lbs) requiring life-support.
myAir Mobile App	BZD (Layered)	21 CFR 868.5905	Class II	Connected software to track patient compliance, leak rates, and therapy quality.

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What is the 510(k) Clearance Genealogy of the AirSense CPAP/APAP Platform?

The AirSense series represents the high-volume core of ResMed's business. The platform transitioned from the S9 generation to the AirSense 10 in 2014, and subsequently to the AirSense 11 in 2021. Understanding the clearance genealogy reveals how ResMed maintains market access through incremental 510(k) submissions.

S9 Series (K113564 / K122416)
          |
          v (Incremental modifications & integrated humidifier)
AirSense 10 Family (K141677)
          |
          v (Bluetooth, touchscreen, OTA updates, and myAir setup integration)
AirSense 11 Family (K203126)
          |
          v (AI-driven comfort recommendations integration)
Smart Comfort AI / PTCS (K25xxxx / Dec 2025 Clearance)

The AirSense 10 Family

The AirSense 10 platform was cleared under K141677 (cleared in 2014) as the primary baseline.

• Key Predicates: S9 AutoSet / S9 Elite (K113564, K122416).
• Regulatory Focus: The AirSense 10 introduced integrated cellular connectivity, enabling automatic data transfer to ResMed's AirView compliance database. The clearance focused on verifying that the wireless module did not cause electromagnetic interference with the device's pressure-delivery algorithm.

The AirCurve 10 ASV Safety Labeling Update

The AirCurve 10 Adaptive Servo-Ventilator (ASV) is a bilevel device designed to treat central and complex sleep apnea. In 2016, ResMed updated its labeling under K160822 following the SERVE-HF clinical trial. This trial, a major post-market study, identified an increased risk of cardiovascular mortality in patients with chronic, symptomatic heart failure (NYHA 2-4) and reduced left ventricular ejection fraction ($\le 45%$). This update represents a vital regulatory gate where post-market clinical trials forced a Class II labeling restriction to mitigate patient risk, establishing an absolute contraindication that remains in place today.

The AirSense 11 Family

Cleared by the FDA on August 19, 2021 under K203126, the AirSense 11 is ResMed's flagship sleep-apnea platform.

• Design Modifications: The AirSense 11 introduced a color touchscreen, integrated bluetooth connectivity, over-the-air (OTA) software updates, and a redesigned integrated humidifier.
• Software Enhancements: The submission included "Personal Therapy Assistant" via the myAir app to guide patients through setup and early compliance tracking.
• Testing Protocols: FDA review for K203126 required extensive biocompatibility evaluation under ISO 10993-1, particularly focusing on volatile organic compounds (VOCs) and particulate matter emitted by the air path, a key regulatory concern highlighted by concurrent competitive recalls.

Summary of Key ResMed Sleep-Apnea Clearances

K-Number	Clearance Date	Device Name(s)	Primary Product Code	Key Regulatory Changes / Features
K113564	2012-02-14	S9 AutoSet / S9 Elite	BZD	Baseline platform; compliance tracking.
K141677	2014-08-08	AirSense 10 Series	BZD	Integrated cellular modem; compliance database connection.
K160822	2016-07-15	AirCurve 10 ASV	BZD	Labeling update implementing SERVE-HF trial contraindications.
K203126	2021-08-19	AirSense 11 Platform	BZD	Touchscreen interface, Bluetooth module, OTA updates, and VOC gas-path biocompatibility testing.
K241216	2024-09-26	myAir App (Standalone)	BZD	Software-as-a-Medical-Device (SaMD) baseline for mobile compliance tracking.
K241939	2024-09-27	EasyCare Tx 2	BZD	Clinical remote titration software for diagnostic labs.

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What is Smart Comfort and Why is its Dec 2025 Clearance a Regulatory First?

On December 8, 2025, ResMed announced it had received FDA 510(k) clearance for its new AI-enabled software feature, marketed as Smart Comfort (submitted to the FDA under the name Personalized Therapy Comfort Settings [PTCS]).

This clearance represents a major milestone: Smart Comfort is the first FDA-cleared AI-enabled digital medical device that recommends personalized comfort settings for patients undergoing CPAP therapy.

1. The Algorithm and Data Source

The Smart Comfort algorithm utilizes machine-learning models trained on more than 100 million nights of de-identified, real-world sleep-apnea therapy data. The algorithm analyzes:

• Patient compliance history.
• Leaking rates and pressure profiles.
• Demographics (age, gender).
• Apnea-Hypopnea Index (AHI) response trends.
• Subjective patient feedback submitted via the myAir app.

Based on these inputs, the AI engine predicts which comfort settings (such as expiratory pressure relief [EPR], ramp time, humidity level, or tube temperature) will maximize patient adherence and comfort, without reducing clinical efficacy.

2. Regulatory Control and Human-in-the-Loop Design

To secure Class II clearance, ResMed utilized a "human-in-the-loop" model. The software does not automatically change the pressure settings of the CPAP machine. Instead:

1. The AI generates a customized recommendation.
2. The recommendation is pushed to the patient's myAir app.
3. The patient must review and explicitly accept the recommendation.
4. Once accepted, the settings are transmitted wirelessly to the AirSense 11 device.

This design prevents unmitigated clinical risks, such as accidental over-pressurization, and satisfies the FDA's special controls for clinical decision support (CDS) systems. Under the FDA's 2022 Clinical Decision Support Final Guidance, software that automatically executes changes without a clinician or patient review is classified as "active" medical device software and requires much higher levels of clinical evidence. By implementing a patient-driven confirmation loop, ResMed successfully mitigated safety concerns while maintaining a seamless user experience.

3. Launch Timeline and Clinical Scope

ResMed is launching Smart Comfort in a limited US beta in early 2026, with a broader commercial rollout planned for later in the year. Initially, the feature will be available exclusively to patients using the AirSense 11 platform in the United States.

The clinical need is substantial: ResMed notes that approximately 61 million people in the United States suffer from obstructive sleep apnea, a figure projected to grow to nearly 77 million by 2050 due to demographic shifts and rising obesity rates. Improving early compliance (which typically hovers around 60-70%) is critical to reducing long-term cardiovascular risks associated with untreated OSA.

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How are ResMed's Life-Support Astral Ventilators Regulated?

The Astral series (Astral 100 and Astral 150) represents ResMed's continuous ventilator platform, designed for patients requiring partial or complete mechanical life-support.

1. The Regulatory History

The Astral platform was first cleared in 2014 under K133868. It was subsequently updated under K152068 (2016) and K172875 (decision date: April 26, 2018).

• Scope of Clearance: The 510(k) updates added compatibility with new breathing circuits, integrated oxygen sensors, and software features like the "Learn Circuit" utility, which measures circuit resistance to optimize volume delivery.
• Product Code Split: Unlike the AirSense, the Astral line is cleared under CBK (Continuous Ventilator, Facility Use) as its primary code, and NOU (Continuous Ventilator, Home Use) as its secondary code, under 21 CFR 868.5895.

2. COVID-19 Era and Emergency Utilization

During the COVID-19 pandemic, demand for life-support ventilators surged. Because the Astral 100/150 was already cleared under 21 CFR 868.5895, ResMed was able to scale manufacturing and distribute these devices globally without relying on temporary Emergency Use Authorizations (EUAs). The Astral's dual-battery design, internal compressor, and ability to support both invasive (tracheostomy) and non-invasive (mask) ventilation made it a critical asset in transition care.

3. Safety Monitoring and Recalls

Operating under product code CBK requires strict post-market surveillance. In September 2023, ResMed initiated a field safety correction for certain Astral 100/150 ventilators (manufactured 2013-2019) because a degrading supercapacitor could cause the Total Power Failure alarm to sound for less than 2 minutes — or in some cases not sound at all — during a complete power loss. The ventilator itself continues to deliver therapy; the issue is the backup alarm's duration. The FDA classified the action as a Class I recall (Recall Number Z-0111-2024, 510(k) K172875), and ResMed's correction combined a software update (Astral Software Release 6.2, deployed from March 2024) with circuit-board service for units identified as affected, while instructing patients to keep devices on mains power. The nature of this issue — an alarm-duration defect corrected through software — differs from competitor Philips' PE-PUR foam degradation, which involved abatement foam breaking down into particles and gases inside the breathing circuit across millions of devices.

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ResMed's Software and Connected Care Layer

In modern medtech, software is a core differentiator. ResMed has built a robust, separately cleared software ecosystem to support its physical hardware:

1. myAir Companion App (510(k) K241216)

Cleared in 2024, the myAir app is a patient engagement platform. It receives Bluetooth data from the AirSense 11 and displays a daily "myAir score" based on:

• Usage hours.
• Mask seal quality.
• Events per hour (AHI).
• Number of mask on/off occurrences.

By securing a formal 510(k) for myAir under K241216, ResMed established a regulatory baseline that allows it to incorporate medical-decision tools—like the Smart Comfort AI engine—directly into the patient-facing interface.

2. Clinical Adherence Evidence

The integration of myAir has direct clinical-support value. ResMed reports that connected, app-supported patient engagement is associated with higher CPAP adherence in early therapy — the period when adherence is otherwise most likely to lapse. Engaged digital coaching matters because commercial payers and Medicare require documented compliance data (such as the CMS "30-day compliance rule" of $\ge 4$ hours per night for $70%$ of nights within a 30-day period) to sustain reimbursement; the myAir app and AirView backend surface exactly those usage metrics to clinicians and billing offices.

3. EasyCare Tx 2 (510(k) K241939)

Cleared in late 2024, EasyCare Tx 2 is a clinical titration software. It allows sleep lab clinicians to remotely monitor and adjust ResMed devices during overnight titration studies, reducing the need for manual bedside adjustments and accelerating the pathway to home therapy prescriptions.

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Competitive Analysis: ResMed vs. Philips and the Sleep Apnea Market Realignment

The sleep-apnea device market underwent a structural realignment following the June 2021 recall of Philips Respironics' DreamStation CPAP and BiPAP devices. This recall, caused by the degradation of polyester-based polyurethane (PE-PUR) sound abatement foam, removed Philips from active competition and triggered a massive shift in global market share.

Sleep Apnea Device Market Share Evolution (Estimated)

2020 (Pre-Recall)
=====================================
ResMed:     [###############] ~45-50%
Philips:    [###########] ~35-40%
Others:     [####] ~10-15%

2026 (Post-Recall & Consent Decree)
=====================================
ResMed:     [#####################] ~60-65%
Philips:    [###] ~5-10% (US Market Exit)
Others:     [######] ~25-30% (Fisher & Paykel, Lowenstein, BMC)

1. The Market Share Shift

• Pre-Recall (2020): ResMed and Philips Respironics controlled over 80% of the global sleep-apnea devices market. ResMed held approximately 45-50%, while Philips held about 35-40% (with a 37% share in the United States per iData Research).
• Post-Recall (2024-2026): ResMed captured the majority of the displaced demand, pushing its share of the obstructive sleep apnea (OSA) treatment market to an estimated 50-60% globally, and significantly higher in the United States. Competitors like Fisher & Paykel Healthcare, BMC Medical, and Löwenstein Medical also expanded, but ResMed remains the primary beneficiary.

2. The US Consent Decree and Philips' Exit

In early 2024, Philips Respironics entered into a consent decree with the US Department of Justice and the FDA; the consent decree was entered by a federal court on April 9, 2024. Under the terms of the decree, Philips agreed to stop selling new sleep-apnea machines and certain ventilators in the United States until it satisfies extensive remediation and quality system improvements. This agreement effectively handed ResMed near-monopoly positioning in the US new-patient CPAP market through 2025 and 2026. The financial impact was stark: the June 2021 recall ultimately impacted approximately 15 million devices worldwide (per FDA), the majority in the first-generation DreamStation family, resulting in billions in write-downs and litigation settlements.

3. Strategic Comparison: Footprint Resilience

• Acoustic Abatement Materials: Unlike Philips Respironics' DreamStation devices, which used a polyester-based polyurethane (PE-PUR) sound-abatement foam that could degrade into particles and volatile organic compounds (VOCs) in the air path, ResMed's AirSense platforms were not subject to the 2021 PE-PUR class of recall. ResMed publicly stated that its sleep-apnea devices use different sound-abatement materials and were unaffected by the foam-degradation issue that drove Philips' recall and US consent decree.
• Supply Chain Response: Although ResMed faced semiconductor shortages during the peak demand surge of 2022-2023, its single-platform design (AirSense 11) allowed it to streamline manufacturing and optimize delivery, ultimately out-shipping competitors and locking in durable clinical placements.

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Global Market Access and Regulatory Expansion

Beyond the United States, ResMed maintains a complex network of local registrations to support its worldwide sales:

1. Europe (CE Marking and EUDAMED)

ResMed transitioned its core portfolio to the EU Medical Device Regulation (MDR 2017/745), securing certificates from Notified Body TÜV SÜD. Under the MDR:

• CPAP machines are Class IIa devices (Rule 9, active therapeutic devices).
• Life-support ventilators are Class IIb (Rule 9, active therapeutic devices intended to administer or exchange energy).
• ResMed Ltd (Bella Vista, Australia) is registered as a non-EU manufacturer, utilizing local subsidiaries (such as ResMed SAS in France) as its European Authorized Representative (EC REP). The company maintains active Actor Registration on the EUDAMED database and assigns Basic UDI-DIs to all device families.

2. Australia (TGA Sponsor-Manufacturer Mapping)

As an Australian-founded company, ResMed utilizes a Sponsor-Manufacturer map to register its devices on the Australian Register of Therapeutic Goods (ARTG). The manufacturer of record is ResMed Ltd in Bella Vista, NSW. To sell locally, ResMed acts as its own sponsor or utilizes specialized local distributors to clear products through the Therapeutic Goods Administration (TGA) Class IIa and Class IIb pathways.

3. Japan (PMDA Shonin Approvals)

In Japan, ResMed products undergo the PMDA's strict "Shonin" approval route. Continuous ventilators require a comprehensive clinical data dossier and local manufacturing site inspections (MHLW Ordinance No. 169) to verify that ResMed's assembly lines in Australia and Singapore meet Japanese Quality Management System (QMS) standards.

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Frequently Asked Questions (FAQ)

What FDA product code applies to the ResMed AirSense 11 CPAP machine?

The ResMed AirSense 11 is cleared under product code BZD (21 CFR 868.5905, Non-continuous ventilator/IPPB), Class II. It is not regulated as a life-support ventilator.

Is ResMed Smart Comfort a separate 510(k) clearance from the AirSense 11 device?

Yes. Smart Comfort (submitted as Personalized Therapy Comfort Settings, PTCS) was cleared as a separate software-only 510(k) on December 8, 2025. It layers on top of the AirSense 11 platform by integrating with the myAir app.

What FDA product codes govern the ResMed Astral life-support ventilator?

The Astral 100 and Astral 150 ventilators are cleared under product code CBK (Continuous Ventilator, Facility Use) as their primary code, and NOU (Continuous Ventilator, Home Use) as their secondary code, under 21 CFR 868.5895.

How does the myAir app affect reimbursement for ResMed CPAP machines?

Payers, including Medicare, require proof of compliance (usage $\ge 4$ hours/night for $70%$ of nights) within the first 90 days. The myAir app helps patients monitor this compliance, and its backend connects to AirView, which transmits compliant data reports directly to clinicians and billing offices to secure ongoing reimbursement.

How much of the sleep-apnea device market does ResMed hold versus Philips?

Following Philips' PE-PUR foam recall and its subsequent agreement under a DOJ consent decree to stop selling sleep-apnea machines in the US, ResMed's market share has risen to an estimated 50-60% globally and is substantially higher in the US new-patient market.

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Sources

1. US FDA 510(k) Premarket Notification Database:
   • AirSense 11 Clearance: K203126 Summary (August 19, 2021).
   • AirCurve 10 ASV Safety Update: K160822 Summary (July 15, 2016).
   • Astral 100/150 Clearance: K172875 Summary (April 26, 2018).
   • myAir Mobile App: K241216 Summary (September 26, 2024).
   • EasyCare Tx 2 titration software: K241939 Summary (September 27, 2024).
2. US FDA MAUDE Database:
   • Adverse Event Report Search: AirSense 11 AutoSet Product Code BZD.
3. ResMed Investor Relations & Corporate News:
   • Smart Comfort / PTCS Clearance Announcement: ResMed Press Release (December 8, 2025).
4. Trade Press & Market Research:
   • MassDevice: ResMed wins FDA clearance for AI-enabled CPAP device (December 8, 2025).
   • ProPublica: Philips Agrees to Stop Selling Sleep Apnea Machines in the US (January 29, 2024).
   • MarketsandMarkets Sleep Apnea Devices Market Report: Market Size and Competitor Analysis (2024-2025).