Name: FDA 510(k) Review Time Dataset
Creator: ADB Consulting and CRO Inc.

How long does FDA 510(k) review take?

FDA cleared 510(k) submissions in a median of 126 days in 2025, the most recent complete year, with a 90th percentile of 267 days across 3,198 decisions, according to ADB Consulting and CRO Inc.'s analysis of FDA's public openFDA device clearance data. 2025 is the headline year used throughout this page; the 2026 figures below are year to date only and are right censored, meaning they will rise as the submissions still pending FDA review are eventually decided, so they are not yet comparable to a completed year. The 2025 median is down from 129 days in 2024 and from a 2022 peak of 143 days, continuing a gradual decline since 2022.

By Decision Year

Review Times Are Trending Down Since the 2022 Peak

* 2026 is year to date through October 29, 2026 and is right censored. Pending submissions are not yet decided and are not in this chart; the final 2026 figures will be higher once the year closes.

FDA 510(k) review days (date received to decision date), by decision year. Source: openFDA device/510k, pulled October 29, 2026.
Year	Decisions	Median Days	Mean Days	P75 Days	P90 Days
2021	2,993	135	168.6	231	340
2022	3,187	143	185	256	396
2023	3,299	135	176.3	245	358
2024	3,082	129	158.6	228	270
2025	3,198	126	146.1	213	267
2026 (YTD through 2026-10-29)	2,645	132	152.1	230	268

By Review Panel · 2025

Which FDA Review Panels Move Fastest

FDA routes every 510(k) to one of its medical specialty review panels (advisory committees). Panel assignment follows device type, not sponsor choice, and panel workload is one driver of how long a submission sits in queue.

By FDA review panel, 2025, sorted by decision volume.
Panel	Code	Decisions	Median Days	P90 Days
Radiology	RA	478	144.5	265
Orthopedic	OR	404	87	260
General, Plastic Surgery	SU	379	91	258
Cardiovascular	CV	349	132	268
Gastroenterology, Urology	GU	258	137.5	266
Dental	DE	228	116	271
Neurology	NE	218	126	267
General Hospital	HO	188	121	267
Microbiology	MI	120	153	268
Physical Medicine	PM	111	111	268
Anesthesiology	AN	99	189	272
Obstetrics/Gynecology	OB	93	154	267
Unknown	UN	63	140	273
Clinical Chemistry	CH	53	158	269
Ear, Nose, Throat	EN	44	163.5	266
Ophthalmic	OP	38	157.5	281
Hematology	HE	22	97	270
Clinical Toxicology	TX	21	50	265
Immunology	IM	19	231	268
Pathology	PA	13	239	397

By Product Code · 2025

Top 25 Product Codes by 510(k) Volume

Review time varies by product code within the same panel. These are the 25 highest volume FDA product codes for 510(k) decisions in 2025.

Top 25 FDA product codes by 510(k) decision volume, 2025.
#	Product Code	Panel	Decisions	Median Days
1	QIH	Radiology	94	150
2	GEX	General, Plastic Surgery	83	90
3	LLZ	Radiology	58	173
4	IYN	Radiology	57	124
5	HRS	Orthopedic	54	90
6	GEI	General, Plastic Surgery	52	113
7	OHS	General, Plastic Surgery	42	88.5
8	NHA	Dental	40	146.5
9	OLO	Neurology	40	119
10	DZE	Dental	31	184
11	ITI	Physical Medicine	29	90
12	MAX	Orthopedic	29	85
13	DXN	Cardiovascular	28	141.5
14	JAK	Radiology	27	141
15	MBI	Orthopedic	27	58
16	LNH	Radiology	26	122
17	HGX	Obstetrics/Gynecology	26	121.5
18	OHT	General, Plastic Surgery	25	87
19	NKB	Orthopedic	24	61
20	LZA	General Hospital	24	109.5
21	OWB	Radiology	22	147.5
22	DQK	Cardiovascular	22	94.5
23	DQY	Cardiovascular	21	115
24	GCJ	Gastroenterology, Urology	21	108
25	JWH	Orthopedic	20	55

Decision Type Mix

Nearly All 510(k) Decisions Are a Substantially Equivalent Finding

FDA records a decision code with every 510(k) determination. Substantially Equivalent (SESE) is the clearance decision itself and accounts for more than 99 percent of decisions in every year in this dataset. A small number of decisions each year carry a different code (for example SESK or SESU), each representing a narrower substantial equivalence finding FDA tracks separately.

Decision type mix by year.
Year	Total Decisions	SESE Count	SESE Share	Other Codes
2021	2,993	2,980	99.6%	SESK (8), SESU (5)
2022	3,187	3,178	99.7%	SESK (5), SESU (3), SESD (1)
2023	3,299	3,283	99.5%	SESU (9), SESK (7)
2024	3,082	3,074	99.7%	SESU (6), SESK (2)
2025	3,198	3,186	99.6%	SESK (6), SESU (5), SESD (1)
2026 (YTD)	2,645	2,643	99.9%	SESK (2)

Third Party Review vs. Direct FDA Review

FDA Accredited Third Party Review Is Rare, and Faster

A small share of 510(k)s, typically under two percent of decisions each year, go through an FDA accredited third party reviewer rather than direct FDA review. Third party reviewed submissions have cleared markedly faster in every year in this dataset, though the volume is too small to generalize broadly to every device type.

Third party review vs. direct FDA review, median days, by year.
Year	Third Party Decisions	Third Party Median Days	Direct Decisions	Direct Median Days
2021	73	31	2,920	137.5
2022	68	29	3,119	147
2023	68	25.5	3,231	139
2024	54	28	3,028	131
2025	60	27	3,138	127
2026 (YTD)	52	28	2,593	134

Method

How This Dataset Was Built

Source: FDA's public openFDA device clearance endpoint, https://api.fda.gov/device/510k.json, a machine readable mirror of FDA's own 510(k) premarket database.
Pull date: October 29, 2026. FDA's own last updated date on the source data as of this pull was October 19, 2026.
Date range: January 1, 2021 through October 29, 2026, covering the last five complete calendar years plus the current year to date.
510(k) only, De Novo excluded: openFDA's device/510k endpoint also returns De Novo grant records in the same response (identified by a K number prefix of DEN rather than K). This dataset excludes those; 199 De Novo grant records in this date range were removed before any statistic on this page was computed, since a De Novo grant is not a 510(k) decision.
Other exclusions: records with a missing receipt or decision date, a negative day span, or a span over 1,500 days are also excluded. 0 records were removed under these rules in this pull.
What review days measures: the number of calendar days from FDA's recorded receipt of the submission to its recorded decision date. This is FDA's own calendar span, and it includes any time the sponsor spent preparing a response to an Additional Information request or otherwise holding the submission open. It is not a measure of FDA's internal review clock days, which pause during a sponsor hold.
Year to date figures are right censored, and 2025 is the headline year on this page. A submission still pending FDA review at the time of a given pull has no decision date yet and is not in this dataset at all, and submissions that take longer than average are disproportionately likely to still be pending at any given moment. For this reason, the current year's median and percentile figures are provisional and will rise, sometimes substantially, as the remaining submissions are eventually decided. 2025, the most recently completed full year, is used as the headline figure throughout this page rather than the partial current year.
Refresh cadence: quarterly, rebuilt from a fresh openFDA pull using the committed build script (scripts/data-asset/build-510k-review-times.mjs). The tables and chart on this page are never hand edited between refreshes.
Reuse: this dataset may be reused with attribution to "ADB Consulting and CRO Inc., 510(k) review time dataset, https://adbccro.com/data/510k-review-times".

Prepared by ADB's Regulatory Team

Reviewed by Andre D. Butler, medical device regulatory consultant, CQA, CCRP

This dataset and its method notes were prepared and reviewed by ADB's regulatory team from FDA's own public openFDA data. ADB Consulting and CRO Inc. does not generate, audit, or submit this data to FDA; it is published for reference, and it is refreshed each quarter from a fresh openFDA pull.

How long does FDA 510(k) review take? Clearance times by year, panel and product code (FDA data, updated October 2026)