FDA Review Panels · 20 specialty panels · 174,773 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 174,773 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
174773
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 · 174,773 records
Panel Submissions Cleared Avg days Last 2y Denied avg
General & Plastic Surgery SU 18,138 97.5% 114d 138d 430d
Cardiovascular CV 17,980 99.1% 124d 152d 338d
Orthopedic OR 17,765 95.8% 119d 116d 357d
General Hospital HO 17,724 99.5% 128d 157d 468d
Radiology RA 15,450 99.8% 106d 146d 258d
Chemistry CH 13,209 99.7% 88d 210d 235d
Dental DE 12,528 99.8% 127d 161d 279d
Gastroenterology & Urology GU 9,812 99.5% 130d 154d 292d
Anesthesiology AN 8,946 99.0% 138d 212d 500d
Microbiology MI 7,032 99.1% 100d 168d 275d
Neurology NE 6,213 98.9% 146d 154d 419d
Physical Medicine PM 5,427 96.9% 112d 149d 462d
Ophthalmic OP 5,090 99.4% 108d 176d 403d
Obstetrics & Gynecology OB 4,463 99.6% 160d 164d 292d
Ear, Nose, Throat EN 3,790 99.4% 88d 168d 320d
Immunology IM 3,776 99.6% 104d 215d 158d
Hematology HE 3,290 99.7% 112d 158d 394d
Toxicology TX 3,024 99.7% 86d 92d 284d
Pathology PA 1,097 97.9% 74d 226d 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 134 days in recent submissions.

Fastest (last 2 years)
92d
3,024 submissions · 99.7% cleared
Slowest (last 2 years)
226d
1,097 submissions · 97.9% 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
18,138 submissions 138d avg (2y)
Cardiovascular
17,980 submissions 152d avg (2y)
Orthopedic
17,765 submissions 116d avg (2y)
General Hospital
17,724 submissions 157d avg (2y)
Radiology
15,450 submissions 146d avg (2y)
Chemistry
13,209 submissions 210d avg (2y)
Dental
12,528 submissions 161d avg (2y)
Gastroenterology & Urology
9,812 submissions 154d avg (2y)
Anesthesiology
8,946 submissions 212d avg (2y)
Microbiology
7,032 submissions 168d avg (2y)
Neurology
6,213 submissions 154d avg (2y)
Physical Medicine
5,427 submissions 149d avg (2y)
Ophthalmic
5,090 submissions 176d avg (2y)
Obstetrics & Gynecology
4,463 submissions 164d avg (2y)
Ear, Nose, Throat
3,790 submissions 168d avg (2y)
Immunology
3,776 submissions 215d avg (2y)
Hematology
3,290 submissions 158d avg (2y)
Toxicology
3,024 submissions 92d avg (2y)
Pathology
1,097 submissions 226d 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 .