FDA 510(k) Review Time: How Long Does Clearance Take?
Based on 175,730 FDA submissions · Data sourced from FDA public files · Updated September 2026
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 - 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 | 3,016 | ||
| Orthopedic | 119d | 17,174 | ||
| General & Plastic Surgery | 114d | 17,827 | ||
| Physical Medicine | 113d | 5,296 | ||
| Radiology | 107d | 15,586 | ||
| Cardiovascular | 124d | 17,919 | ||
| Microbiology | 100d | 6,997 | ||
| Neurology | 146d | 6,221 | ||
| Dental | 127d | 12,581 | ||
| Gastroenterology & Urology | 130d | 9,827 | ||
| General Hospital | 128d | 17,700 | ||
| Ear, Nose, Throat | 88d | 3,793 | ||
| Hematology | 112d | 3,284 | ||
| Ophthalmic | 109d | 5,077 | ||
| Obstetrics & Gynecology | 160d | 4,481 | ||
| Chemistry | 88d | 13,190 | ||
| Pathology | 75d | 1,083 | ||
| Anesthesiology | 138d | 8,898 | ||
| Immunology | 104d | 3,773 | ||
| Medical Genetics Slowest | 317d | 12 |
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.