FDA 510(k) Review Time: How Long Does Clearance Take?

Based on 174,883 FDA submissions · Data sourced from FDA public files · Updated June 2026

149d

Avg cleared 2025

▼ 10d vs 2024

185d

Peak year (2022)

▲ Highest on record

337d

Avg denied submission

▲ 2.3× cleared avg

90d

FDA target (MDUFA IV)

▲ Rarely achieved

510(k) Review Time at a Glance

Metric	Days
FDA MDUFA target (standard 510k)	90d
All-time average (cleared, 2000–2025)	129d
Average cleared - last 2 years	149d
Average cleared - 2025	146d
Average denied submission	337d
Fastest panel - last 2 years (Toxicology)	90d
Slowest panel - last 2 years (Immunology)	227d

Average 510(k) Review Time by Year (2000–2025)

Average days from FDA acceptance to decision for cleared 510(k) submissions. Source: 510k Database - 174,883 records.

510(k) Review Time by FDA Specialty Panel

Review times differ substantially across the 20 FDA specialty panels. The table below shows all-time average, last 2 years average, and average review time for denied submissions - all based on real cleared and denied 510(k) records.

Panel	All-time avg	Last 2 years	Denied avg	Cleared
Toxicology Fastest	86d	90d	284d	3,015
Orthopedic	119d	117d	357d	17,062
General & Plastic Surgery	114d	138d	427d	17,741
Radiology	107d	146d	258d	15,473
Physical Medicine	112d	149d	462d	5,271
Cardiovascular	124d	152d	333d	17,837
Gastroenterology & Urology	130d	154d	292d	9,781
Neurology	146d	155d	419d	6,165
General Hospital	128d	159d	468d	17,664
Dental	127d	159d	279d	12,528
Hematology	112d	161d	394d	3,282
Microbiology	100d	163d	275d	6,978
Obstetrics & Gynecology	160d	164d	292d	4,453
Ear, Nose, Throat	88d	165d	320d	3,774
Ophthalmic	108d	171d	403d	5,067
Chemistry	88d	208d	235d	13,178
Anesthesiology	138d	211d	500d	8,871
Pathology	74d	217d	192d	1,076
Immunology Slowest	104d	227d	158d	3,764

Why Do 510(k) Review Times Vary?

The FDA 510(k) pathway has a statutory 90-day review target under MDUFA IV performance goals. In practice, review times are consistently longer because the 90-day clock stops during any period when the FDA requests additional information from the manufacturer - a process known as an Additional Information Request (AIR) or Hold.

Review times increased steadily from around 100 days in 2000–2006 to a record high of 185 days in 2022. This reflects growing submission volume, increased device complexity, and disruptions caused by the COVID-19 pandemic. The data shows a meaningful reduction since 2023, with 2025 averaging 146 days - the lowest since 2019.

Denied submissions take significantly longer to resolve - an average of 337 days across all panels, compared to 149 days for cleared devices. This reflects the back-and-forth of additional information requests before a final denial decision. The Anesthesiology panel has the longest average denied review time at 500 days.

Manufacturers planning a 510(k) submission should use the last 2 years average for their specific panel as their primary planning benchmark, not the FDA's 90-day target or the all-time average, which reflects historical periods with different FDA workload and processes.

Frequently Asked Questions

How long does a 510(k) submission take in 2025?

The average FDA 510(k) review time in 2025 is 146 days for cleared submissions, based on 3,195 cleared devices. The FDA's official MDUFA target is 90 days, but actual times are consistently higher due to Additional Information Requests (AIRs) where the clock stops. Plan for 5–7 months from acceptance to clearance for most device types.

Which FDA panel has the fastest 510(k) review time?

Toxicology is the fastest panel with a last-2-years average of 90 days, followed by Orthopedic at 117 days. Toxicology's low volume (3,015 cleared devices) and device simplicity contribute to its consistently fast review times.

Which FDA panel has the slowest 510(k) review time?

Immunology has the slowest recent average at 227 days, followed by Pathology (217d) and Anesthesiology (211d). These panels typically review higher-risk or more complex devices that require additional clinical or analytical data.

How long does a denied 510(k) take?

Denied submissions take an average of 337 days - more than twice the average cleared submission. The Anesthesiology panel has the longest denied average at 500 days. The extended timeline reflects multiple rounds of additional information requests before the FDA issues a final Not Substantially Equivalent (NSE) decision.

What is the FDA's 510(k) review time target?

Under the Medical Device User Fee Amendments (MDUFA IV), the FDA committed to reviewing 90% of standard 510(k) submissions within 90 FDA days. Note that "FDA days" excludes time when the submission is on hold for additional information - so the actual calendar time is substantially longer. The FDA's MDUFA performance data is published annually.

Why did 510(k) review times peak in 2022?

The 185-day average in 2022 was the highest since records began. Contributing factors include COVID-19 pandemic disruptions to FDA operations (2020–2021), a backlog of submissions, increased submission volume, and greater device complexity. Review times have improved since 2023 as FDA staffing and processes normalized.

Related Resources

Data source: FDA 510(k) public database, processed and maintained by 510k Database. Dataset includes 174,883 submissions from 1976 to present. Review times calculated from FDA acceptance date to decision date. Updated monthly. · About this dataset