FDA 510(k) Review Time and Clearance Timeline: How Long Does It Take?
The average FDA 510(k) review time is 149 days for cleared submissions in 2025, based on 175,730 real FDA submission records. This page tracks 510(k) clearance timelines by year and by FDA specialty panel, and explains the factors that affect how long a 510(k) submission takes from acceptance to decision.
Based on 175,730 FDA submissions · Data sourced from FDA public files · Updated November 2026
510(k) Review Time at a Glance
Key FDA 510(k) review time benchmarks from 175,730 cleared and denied submissions. The FDA's MDUFA target is 90 days — actual clearance timelines are consistently longer due to Additional Information Requests (AIRs) that pause the review clock.
| Metric | Days |
|---|---|
| FDA MDUFA target (standard 510k) | 90d |
| All-time average (cleared, 2000–2026) | 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 (2000–2026)
Historical FDA 510(k) clearance timeline data from 2000 to 2026. Average review time peaked at 185 days in 2022 and has declined since. Use this chart to understand how 510(k) review times have evolved and contextualize your submission planning against historical benchmarks.
Average days from FDA acceptance to decision for cleared 510(k) submissions. Source: 510k Database - 175,730 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 | 3,017 | ||
| Orthopedic | 119d | 17,228 | ||
| General & Plastic Surgery | 114d | 17,866 | ||
| Physical Medicine | 113d | 5,312 | ||
| Dental | 127d | 12,607 | ||
| Radiology | 107d | 15,634 | ||
| Microbiology | 100d | 7,012 | ||
| Cardiovascular | 125d | 17,959 | ||
| Gastroenterology & Urology | 130d | 9,854 | ||
| Neurology | 146d | 6,243 | ||
| General Hospital | 128d | 17,717 | ||
| Hematology | 112d | 3,286 | ||
| Ear, Nose, Throat | 88d | 3,799 | ||
| Obstetrics & Gynecology | 160d | 4,492 | ||
| Ophthalmic | 109d | 5,081 | ||
| Chemistry | 88d | 13,202 | ||
| Pathology | 75d | 1,084 | ||
| Anesthesiology | 138d | 8,908 | ||
| Immunology | 104d | 3,774 | ||
| Medical Genetics Slowest | 317d | 12 |
Factors Affecting FDA 510(k) Review Time and Clearance Timeline
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. This distinction between FDA days (active review time) and calendar days (total elapsed time) is critical for submission planning.
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.
Special 510(k) Timeline vs Traditional 510(k)
The Special 510(k) pathway is designed for modifications to a manufacturer's own cleared device. The FDA's review goal for Special 510(k)s is 30 calendar days — significantly shorter than the 90-day target for Traditional 510(k)s. However, this timeline only applies when the submission qualifies as a Special 510(k) and the FDA does not issue an AIR. If an Additional Information Request is issued, the review clock stops and the actual clearance timeline extends considerably. Manufacturers should verify with their regulatory consultant whether their device modification qualifies for the Special 510(k) pathway before planning their timeline.
What Are FDA Industry Days in 510(k) Review?
FDA industry days refers to the number of days the FDA actively worked on a submission — excluding time when the submission was on hold for an AIR. This metric appears in FDA MDUFA performance data and differs from the total calendar days from submission to decision. The 510k Database calculates review time using calendar days from acceptance date to decision date, which better reflects actual planning timelines for manufacturers.