FDA Review Panels · 20 specialty panels · 175,340 submissions analyzed

FDA 510(k) Review Panels

The FDA organizes 510(k) medical device submissions into 20 specialty review panels. Each panel groups devices by medical discipline and is staffed by FDA reviewers with domain expertise. Review timelines, clearance rates and submission volumes vary significantly across panels - data below is derived from 175,340 real FDA 510(k) records.

  • Compare review times across all 20 FDA specialty panels
  • Clearance rates and denial averages by panel
  • Updated monthly from official FDA data
20
Review panels
175340
Submissions

What is an FDA 510(k) Review Panel?

The FDA's Center for Devices and Radiological Health (CDRH) organizes 510(k) premarket notifications into 20 specialty review panels, each corresponding to a medical discipline. When a manufacturer submits a 510(k), the FDA assigns it to the relevant panel based on the device's product code.

The panel assignment determines which team of FDA reviewers evaluates the submission and directly influences the typical review timeline. Panels with higher submission volumes and more established predicate libraries tend to have faster review times. What is an FDA review panel? →

FDA 510(k) Review Time by Panel - Complete Comparison

Review times below are calculated from submission date to FDA decision date across all published records in the 510k Database dataset. "Last 2 years" reflects submissions cleared in the most recent 24 months and is the most relevant benchmark for current submission planning.

All 20 FDA Review Panels - Clearance Data

Updated monthly · 175,340 records
Panel Submissions Cleared Avg days Last 2y Denied avg
General & Plastic Surgery SU 18,220 97.5% 114d 137d 427d
Cardiovascular CV 18,029 99.1% 124d 151d 333d
Orthopedic OR 17,849 95.8% 119d 119d 357d
General Hospital HO 17,756 99.5% 128d 160d 468d
Radiology RA 15,537 99.8% 107d 148d 258d
Chemistry CH 13,219 99.7% 88d 207d 235d
Dental DE 12,570 99.8% 127d 160d 279d
Gastroenterology & Urology GU 9,838 99.5% 130d 155d 292d
Anesthesiology AN 8,972 99.0% 138d 217d 492d
Microbiology MI 7,046 99.1% 100d 159d 275d
Neurology NE 6,253 98.9% 146d 154d 419d
Physical Medicine PM 5,449 96.9% 113d 149d 462d
Ophthalmic OP 5,098 99.4% 108d 174d 403d
Obstetrics & Gynecology OB 4,485 99.6% 160d 168d 292d
Ear, Nose, Throat EN 3,804 99.4% 88d 160d 320d
Immunology IM 3,780 99.6% 104d 241d 158d
Hematology HE 3,292 99.7% 112d 158d 394d
Toxicology TX 3,025 99.7% 86d 92d 284d
Pathology PA 1,099 97.9% 74d 212d 192d
Medical Genetics MG 19 57.9% 315d - 515d
All times in calendar days from submission to FDA decision. "Last 2y" = cleared submissions in the last 24 months. Green = faster than historical average. Red = slower. Source: 510k Database dataset derived from FDA 510(k) public files .

Fastest and Slowest FDA 510(k) Review Panels

Review time is one of the most critical planning variables for any 510(k) submission. The panel with the fastest recent average and the panel with the slowest recent average differ by more than 149 days in recent submissions.

Fastest (last 2 years)
92d
3,025 submissions · 99.7% cleared
Slowest (last 2 years)
241d
3,780 submissions · 99.6% cleared

Browse FDA 510(k) Clearances by Medical Specialty Panel

Each panel page includes the full list of cleared devices, FDA review time data, top manufacturers and product code breakdown.

General & Plastic Surgery
18,220 submissions 137d avg (2y)
Cardiovascular
18,029 submissions 151d avg (2y)
Orthopedic
17,849 submissions 119d avg (2y)
General Hospital
17,756 submissions 160d avg (2y)
Radiology
15,537 submissions 148d avg (2y)
Chemistry
13,219 submissions 207d avg (2y)
Dental
12,570 submissions 160d avg (2y)
Gastroenterology & Urology
9,838 submissions 155d avg (2y)
Anesthesiology
8,972 submissions 217d avg (2y)
Microbiology
7,046 submissions 159d avg (2y)
Neurology
6,253 submissions 154d avg (2y)
Physical Medicine
5,449 submissions 149d avg (2y)
Ophthalmic
5,098 submissions 174d avg (2y)
Obstetrics & Gynecology
4,485 submissions 168d avg (2y)
Ear, Nose, Throat
3,804 submissions 160d avg (2y)
Immunology
3,780 submissions 241d avg (2y)
Hematology
3,292 submissions 158d avg (2y)
Toxicology
3,025 submissions 92d avg (2y)
Pathology
1,099 submissions 212d avg (2y)
Medical Genetics
19 submissions

Frequently Asked Questions

What are the FDA 510(k) review panels?

The FDA organizes 510(k) medical device submissions into 20 specialty review panels, each corresponding to a medical discipline such as Orthopedic, Cardiovascular, Radiology or Dental. Each panel is staffed by FDA reviewers with expertise in that device category. The panel assignment determines which team reviews the submission and influences typical review timelines.

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

Review times vary by panel and change over time. Based on the 510k Database dataset, the Toxicology panel has the fastest recent average at 92 days for cleared submissions in the last 2 years. See the full comparison table above for all panels.

How does FDA assign a device to a review panel?

FDA assigns each medical device to a review panel based on its product code and device classification. The product code determines the panel assignment. Manufacturers can identify the relevant panel for their device by searching the FDA product classification database or by reviewing the product code assigned to similar cleared devices.

What is the difference between an FDA review panel and a product code?

An FDA review panel is a broad specialty group - such as Orthopedic or Cardiovascular - that evaluates 510(k) submissions in that medical area. A product code is a more specific 3-letter classification within a panel that identifies the exact device type. Each panel contains dozens or hundreds of individual product codes.

Why do review times differ between panels?

Review times vary due to several factors: the complexity of devices in the panel, the availability of established predicate devices, the volume of submissions the panel handles, and whether the FDA requests additional information. Panels with a long history of cleared devices - such as Orthopedic - tend to have faster review times because predicate pathways are well established.

510k Database is not affiliated with or endorsed by the FDA. Review time data is derived from the FDA 510(k) public files and updated monthly. Always verify submission requirements directly at accessdata.fda.gov .