FDA 510(k) Clearance Statistics 2026
Comprehensive analysis of FDA 510(k) medical device clearances — total counts, decision code breakdowns, average review time, top companies, and product code trends. Sourced from official FDA databases, updated regularly.
Key Figures
| Metric | Value |
|---|---|
| Total 510(k) clearances tracked | 175,879 |
| Clearances in 2026 | 2,082 |
| Company with most clearances | abbott laboratories (889) |
| Most common product code | GEX (2,873 clearances) |
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Overview
The FDA 510(k) process is the most common pathway for medical device market clearance. A 510(k) submission demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device.
Decision Code Breakdown
Each 510(k) submission receives a decision code from the FDA. SESE (Substantially Equivalent) is the most common outcome, meaning the device can be legally marketed. SESD means SE with deficiency noted. DENG means the submission was denied.
Year-over-Year Trends
Annual 510(k) clearance counts showing the trend in FDA device clearance activity over time.
Top Companies by Clearance Volume
The 20 companies with the most FDA 510(k) clearances, based on normalized applicant names.
| # | Company | Clearances |
|---|
Top Product Codes
The 15 most frequently cleared FDA product codes. Each product code identifies a specific type of medical device.
Average Review Time
The average number of calendar days between when the FDA receives a 510(k) submission and when a decision is issued.
Expedited & Third-Party Reviews
The FDA offers expedited review for certain device types and allows accredited third parties to conduct primary review of some 510(k) submissions.
Expedited Review
Third-Party Review
Clearance Types
510(k) submissions are categorized by type: Traditional, Special, and Abbreviated. Each has different documentation requirements and review timelines.
Frequently Asked Questions
How many 510(k)s does FDA clear per year?
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What is a 510(k) clearance?
A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. It is the most common pathway for bringing medical devices to market in the United States, named after Section 510(k) of the Food, Drug, and Cosmetic Act. Unlike PMA (Premarket Approval), 510(k) clearance does not require clinical trials in most cases.
What is the average 510(k) review time?
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What does substantially equivalent mean?
A device is "substantially equivalent" (SE) if it has the same intended use as the predicate device and either has the same technological characteristics or different characteristics that do not raise new safety and effectiveness questions. The FDA decision code SESE indicates a finding of substantial equivalence. SESD means SE was granted but with a deficiency noted in the submission. DENG means the device was found not substantially equivalent (denied).
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