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. Data Sources below shows when each was last refreshed.
When each FDA source behind these statistics was last refreshed
Records
Last refreshed
Source as of
Status
510(k) clearances (openFDA)
Nov 8, 2026
File dated Nov 2, 2026
Current
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Total 510(k) Clearances
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Avg. Days to Clearance
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Substantially Equivalent
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Expedited Review
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
Substantially Equivalent with Drug. SEKD means
Substantially Equivalent - Kit with Drugs. DENG means De Novo granted,
the decision FDA records as granted on a De Novo (DEN) record. It is not a denial.
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Year-over-Year Trends
Annual 510(k) clearance counts showing the trend in FDA device clearance activity over time.
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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.
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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.
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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 Substantially Equivalent with Drug.
SEKD means Substantially Equivalent - Kit with Drugs.
DENG means De Novo granted, the decision FDA records as granted
on a De Novo (DEN) record. It is not a denial.
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Source: RegDataLab, aggregating FDA 510(k) premarket notification
databases. Updated regularly from official FDA sources. This page pulls live data from our
Postgres warehouse via the /api/stats/510k endpoint.