FDA Review Panels · 20 specialty panels · 176,215 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 176,215 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
176215
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 · 176,215 records
Panel Submissions Cleared Avg days Last 2y Denied avg
General & Plastic Surgery SU 18,319 97.5% 114d 136d 423d
Cardiovascular CV 18,127 99.1% 125d 152d 329d
Orthopedic OR 17,984 95.8% 119d 118d 348d
General Hospital HO 17,798 99.5% 128d 160d 463d
Radiology RA 15,666 99.8% 107d 150d 258d
Chemistry CH 13,237 99.7% 88d 175d 238d
Dental DE 12,630 99.8% 127d 151d 279d
Gastroenterology & Urology GU 9,905 99.5% 130d 153d 293d
Anesthesiology AN 9,000 99.0% 138d 216d 492d
Microbiology MI 7,076 99.1% 100d 150d 275d
Neurology NE 6,312 98.9% 146d 154d 419d
Physical Medicine PM 5,480 96.9% 113d 148d 462d
Ophthalmic OP 5,110 99.4% 109d 168d 403d
Obstetrics & Gynecology OB 4,512 99.6% 160d 169d 294d
Ear, Nose, Throat EN 3,822 99.4% 88d 163d 320d
Immunology IM 3,788 99.6% 104d 231d 158d
Hematology HE 3,295 99.7% 112d 165d 394d
Toxicology TX 3,027 99.7% 86d 98d 284d
Pathology PA 1,107 97.9% 75d 214d 192d
Medical Genetics MG 20 60.0% 317d 349d 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 251 days in recent submissions.

Fastest (last 2 years)
98d
3,027 submissions · 99.7% cleared
Slowest (last 2 years)
349d
20 submissions · 60.0% 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
18,319 submissions 136d avg (2y)
Cardiovascular
18,127 submissions 152d avg (2y)
Orthopedic
17,984 submissions 118d avg (2y)
General Hospital
17,798 submissions 160d avg (2y)
Radiology
15,666 submissions 150d avg (2y)
Chemistry
13,237 submissions 175d avg (2y)
Dental
12,630 submissions 151d avg (2y)
Gastroenterology & Urology
9,905 submissions 153d avg (2y)
Anesthesiology
9,000 submissions 216d avg (2y)
Microbiology
7,076 submissions 150d avg (2y)
Neurology
6,312 submissions 154d avg (2y)
Physical Medicine
5,480 submissions 148d avg (2y)
Ophthalmic
5,110 submissions 168d avg (2y)
Obstetrics & Gynecology
4,512 submissions 169d avg (2y)
Ear, Nose, Throat
3,822 submissions 163d avg (2y)
Immunology
3,788 submissions 231d avg (2y)
Hematology
3,295 submissions 165d avg (2y)
Toxicology
3,027 submissions 98d avg (2y)
Pathology
1,107 submissions 214d avg (2y)
Medical Genetics
20 submissions 349d avg (2y)

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 98 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 .