FDA 510(k) Success Rate, Rejection Statistics & Common Reasons (2026)

How Often Do 510(k) Submissions Actually Succeed?

The FDA 510(k) pathway is the most common route to market for medical devices in the United States, with approximately 3,200 clearances per year. But the journey from submission to clearance is far from guaranteed, and the statistics reveal important patterns that can shape your regulatory strategy.

Understanding where submissions fail — and why — is one of the most valuable things you can do before preparing your own 510(k). This guide breaks down the latest data on success rates, review timelines, and the most common reasons for rejection, with specific strategies to avoid them.

Key 510(k) Statistics at a Glance (2025–2026)

Metric	Figure	Source
Total 510(k) clearances (2025)	~3,195	FDA public data
Total 510(k) clearances (2024)	~3,082	FDA public data
Average review time (2025)	~146 days	510kDatabase.net
Average review time (2026 YTD)	~147 days	510kDatabase.net
Submissions receiving SE decision	~85%	FDA data (FY2022)
Submissions receiving at least one AI request	~67%	FDA data (FY2022)
Submissions hitting RTA hold at least once	~33%	FDA/industry data
Historical RTA refusal rate (early program)	Up to ~60%	Complizen.ai analysis

Understanding the Three Review Gates

Before diving into the statistics, it helps to understand the three critical checkpoints every 510(k) must pass:

Gate 1: Refuse to Accept (RTA) Review

The FDA's initial administrative check determines whether your submission meets the minimum threshold for review. This is not a scientific evaluation — it is a structured, criteria-driven assessment using detailed RTA checklists covering device description, indications for use, labeling, performance testing, biocompatibility, cybersecurity, sterilization, and more.

Current RTA hold rate: approximately 33% of submissions receive an RTA hold at least once.

When the RTA program was first introduced, up to 60% of new 510(k)s were refused at this stage. While the rate has improved significantly — partly due to the FDA's mandatory eSTAR template introduced in October 2023 — RTA remains one of the most common and preventable causes of delay.

Gate 2: Substantive Review and Additional Information (AI) Requests

If your submission passes the RTA check, it enters substantive review. During this phase, the FDA may issue an Additional Information (AI) request if it needs more data or clarification before making a decision.

Current AI request rate: approximately 67% of 510(k) submissions receive at least one AI request during the first review cycle.

AI requests add significant delays and costs. The FDA's review clock pauses while you prepare your response, and the quality of your AI response directly impacts whether your submission proceeds to clearance.

Gate 3: Substantially Equivalent (SE) vs. Not Substantially Equivalent (NSE)

The final decision. If the FDA agrees your device is substantially equivalent to the predicate, you receive an SE (Substantially Equivalent) letter and can market your device in the US. If not, you receive an NSE determination.

Current SE rate: approximately 85% of submissions that enter review receive an SE decision. This means roughly 15% of submissions do not obtain clearance.

Review Timeline Breakdown

The time from submission to clearance varies significantly based on submission quality and complexity:

Timeline Category	Days	Percentage of Clearances
Fast Track	Under 90 days	~24%
Standard	90–150 days	~34%
Extended	150–200 days	~20%
Complex	Over 200 days	~22%

For AI/ML-enabled medical devices specifically, 2025 data shows a median clearance time of 142 days with an average of 150 days, across 295 total clearances from 221 unique manufacturers.

The 7 Most Common Reasons 510(k) Submissions Fail

Based on FDA data, industry analysis, and regulatory consultant experience, these are the most frequent causes of RTA holds, AI requests, and NSE determinations:

1. Administrative Incompleteness (RTA Stage)

This is the single most common reason submissions fail before substantive review even begins. Missing or inadequately addressed items on the RTA checklist trigger an immediate hold.

Common triggers:

• Missing sections that should include a "not applicable" statement
• Using outdated FDA forms (Form 3601, Form 3514, Form 3381)
• Invalid eCopy or incomplete eSTAR submission
• Incorrect user fee payment amount or reference number
• Missing Truthful and Accuracy statement

Real-world RTA examples (representative industry cases frequently cited by regulatory consultants):

• An ECG manufacturer received an RTA hold because the submission did not include a comprehensive description of its proprietary signal processing algorithm — the FDA could not evaluate performance claims without understanding the core technology
• A microneedling device submission was held because clinical trial data included only a summary of results without statistically significant improvements over the predicate device

How to avoid it: Use the FDA's eSTAR template (mandatory since October 2023) and work through the RTA checklist methodically before submission. Every section must either contain complete information or a justified "not applicable" statement. Using outdated FDA forms (Form 3601, Form 3514, Form 3381) is a common and easily preventable RTA trigger.

2. Poor Predicate Device Selection

Choosing the wrong predicate is a strategic error that can derail your entire submission. If your predicate is too dissimilar, the FDA will struggle to evaluate substantial equivalence.

Common mistakes:

• Selecting a predicate with a different intended use
• Choosing a predicate with significantly different technological characteristics
• Using a recalled predicate (44.1% of Class I recalled devices used a recalled predicate, according to CEPR research)
• Not adequately addressing differences between your device and the predicate

How to avoid it: Conduct thorough research in the FDA 510(k) database. Consider filing a Pre-Submission (Q-Submission) meeting with the FDA to discuss predicate selection before committing to your strategy.

3. Inadequate Device Description

The FDA requires a clear and complete description of your device, its technological characteristics, and how it compares to the predicate. Vague or incomplete descriptions are a frequent cause of AI requests and NSE determinations.

What the FDA expects:

• Detailed physical and functional description
• Clear description of all operating principles
• Complete materials characterization
• Software architecture and algorithms (for software-driven devices)
• Comparison tables highlighting similarities and differences to the predicate

4. Insufficient Performance Testing Data

Performance testing is the backbone of your substantial equivalence argument. Missing, incomplete, or poorly designed testing is a leading cause of AI requests and NSE decisions.

Common testing gaps:

• Bench testing that doesn't cover all claimed performance characteristics
• Missing biocompatibility testing per ISO 10993-1
• Inadequate electromagnetic compatibility (EMC) testing
• Missing cybersecurity documentation for connected devices
• Clinical data that lacks statistical significance
• Software validation and verification gaps

How to avoid it: Develop a comprehensive test plan early in development. Reference FDA device-specific guidance documents and recognized consensus standards. For clinical data, ensure your study protocol is designed to demonstrate statistically significant improvements or equivalence.

5. Cybersecurity Documentation Deficiencies

Since the FDA updated its premarket cybersecurity guidance in February 2026 — aligned with the new QMSR — cybersecurity documentation has become a major review focus. Connected devices (any device with software and network connectivity, including USB, Bluetooth, or Wi-Fi) must now provide:

• Software Bill of Materials (SBOM) — legally required under Section 524B of the FD&C Act
• Security architecture views (global system, multi-patient harm, updateability, security use case)
• Threat modeling documentation
• Penetration testing and vulnerability assessment results
• Plan for post-market vulnerability management

How to avoid it: Integrate cybersecurity into your design controls from the start. Follow the FDA's February 2026 guidance document "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions" closely.

6. Labeling Issues

Labeling deficiencies are a surprisingly common cause of delays. The FDA reviews your proposed labeling carefully and expects it to be consistent with your indications for use and performance data.

Common labeling problems:

• Inconsistencies between labeling and 510(k) content
• Missing or inadequate instructions for use
• Claims not supported by performance data
• Missing contraindications, warnings, or precautions
• Inadequate patient labeling for consumer-facing devices

7. Inadequate Risk Analysis

A weak risk analysis that fails to identify all relevant hazards, underestimate severity, or propose insufficient mitigations will trigger extensive AI requests and can lead to NSE decisions.

What a strong risk analysis includes:

• Comprehensive hazard identification per ISO 14971
• Analysis covering normal and fault conditions
• Risk-benefit analysis for residual risks
• Traceability from hazards to mitigations to verification activities
• Software-specific risk analysis (including cybersecurity threats)

Strategies to Maximize Your 510(k) Success Rate

Use the Pre-Submission (Q-Submission) Program

The FDA's pre-submission program allows you to get written feedback from reviewers before you submit your 510(k). This is one of the most underutilized tools available. The formal written feedback becomes part of the administrative record and can help resolve questions about predicate selection, testing requirements, and clinical data expectations early.

In the current environment, where FDA reviewer bandwidth is constrained, Q-Submission feedback is even more valuable. There may be longer wait times for feedback, but the de-risking benefit remains significant.

Leverage the eSTAR Template

The eSTAR template, mandatory since October 2023 for 510(k)s and October 2025 for De Novo requests, is designed to reduce RTA holds by ensuring completeness. Use it thoroughly — it includes built-in prompts and checklist items that align directly with the FDA's RTA review criteria.

Invest in a Regulatory Strategy Before Building the File

Many submissions fail because the regulatory strategy was flawed from the start — wrong pathway, wrong predicate, wrong classification, or inadequate testing plan. A clear regulatory roadmap, developed before you begin assembling the submission, is the foundation of a successful 510(k).

Consider Small Business Qualification

If your company has gross receipts or sales of $100 million or less (including affiliates), you qualify for the FDA's Small Business Determination program. This reduces the 510(k) user fee from $26,067 to $6,517 — a savings of $19,550. Companies with $30 million or less in revenue also qualify for a first-time PMA fee waiver worth up to $579,272.

Build for the Current Review Environment

The 2026 regulatory environment presents specific challenges:

• FDA staffing constraints following workforce reductions and attrition have reduced reviewer bandwidth, potentially extending review timelines
• QMSR transition (effective February 2, 2026) means all quality system references must align with the new regulation incorporating ISO 13485:2016
• Cybersecurity requirements under Section 524B are now legally enforceable, with SBOMs mandatory for all cyber devices
• eSTAR is mandatory for De Novo requests as of October 2025

Well-prepared submissions that address these current requirements from the outset will face fewer delays than those requiring extensive remediation.

Year-Over-Year Clearance Trends

Year	Total Cleared	Average Review Days
2026 (partial)	734	147
2025	~3,195	146
2024	~3,082	159
2023	~3,300	176
2022	~3,190	185
2021	~2,991	169

Review times have been improving steadily since 2022, dropping from 185 days to 146 days by 2025. This trend suggests that the eSTAR mandate and process improvements are having a positive effect on review efficiency, even as the volume of clearances has increased.

First-Time Applicants: What the Data Shows

Q3 2025 data reveals that 28% of all 510(k) applicants were first-time submitters, indicating a thriving startup ecosystem. However, first-time applicants typically face longer review timelines than experienced submitters:

• Companies with 2–5 prior clearances are reviewed faster than first-timers
• Companies with 6+ clearances have the fastest review times
• First-time submitters have a higher probability of RTA holds and AI requests

This suggests a "regulatory learning curve" — each successive submission builds institutional knowledge that improves efficiency.

What to Do If You Receive an NSE Determination

An NSE (Not Substantially Equivalent) decision is not the end of the road. Your options include:

1. Submit a new 510(k) with a different predicate or additional data addressing the FDA's concerns
2. Request De Novo classification if your device is novel but presents low-to-moderate risk
3. Pursue a PMA if your device is high-risk and requires clinical evidence
4. Request a reconsideration if you believe the FDA's decision was based on incorrect information

The best approach depends on the specific reasons for the NSE determination. In many cases, a new 510(k) with a stronger predicate and additional data can succeed.

Frequently Asked Questions

What percentage of 510(k) submissions are cleared?

Approximately 85% of 510(k) submissions that enter substantive review receive a Substantially Equivalent (SE) decision. However, this figure only counts submissions that pass the initial RTA check — roughly one-third of submissions receive an RTA hold at least once.

How long does the FDA have to review a 510(k)?

The FDA's target review clock is 90 days for a standard 510(k). However, the average review time in 2025 was approximately 146 days, largely because most submissions receive at least one Additional Information (AI) request that pauses the clock.

What is the RTA hold rate for 510(k) submissions?

Currently, approximately 33% of 510(k) submissions receive an RTA (Refuse to Accept) hold at least once. When the program was first introduced, the rate was as high as 60%. The mandatory eSTAR template has helped reduce this significantly.

Can I resubmit after an NSE determination?

Yes. You can submit a new 510(k) with a different predicate or additional data, pursue a De Novo classification request, or file a PMA application depending on your device's characteristics and risk level.

What is the most common reason for 510(k) failure?

Administrative incompleteness at the RTA stage is the most common preventable cause of delay. Among submissions that enter substantive review, inadequate performance data and poor predicate selection are the most common reasons for NSE determinations.

Does using eSTAR improve my chances of clearance?

The eSTAR template reduces the likelihood of RTA holds by ensuring your submission addresses all required checklist items. While it does not guarantee clearance, it significantly improves your chances of passing the initial administrative review gate.