FDA Review Panels · 20 specialty panels · 175,862 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 175,862 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
175862
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 · 175,862 records
Panel Submissions Cleared Avg days Last 2y Denied avg
General & Plastic Surgery SU 18,280 97.5% 114d 138d 423d
Cardiovascular CV 18,086 99.1% 124d 150d 333d
Orthopedic OR 17,930 95.8% 119d 117d 348d
General Hospital HO 17,781 99.5% 128d 160d 463d
Radiology RA 15,618 99.8% 107d 147d 258d
Chemistry CH 13,225 99.7% 88d 196d 238d
Dental DE 12,604 99.8% 127d 154d 279d
Gastroenterology & Urology GU 9,878 99.5% 130d 154d 293d
Anesthesiology AN 8,990 99.0% 138d 212d 492d
Microbiology MI 7,061 99.1% 100d 151d 275d
Neurology NE 6,290 98.9% 146d 153d 419d
Physical Medicine PM 5,464 96.9% 113d 148d 462d
Ophthalmic OP 5,106 99.4% 109d 167d 403d
Obstetrics & Gynecology OB 4,501 99.6% 160d 167d 294d
Ear, Nose, Throat EN 3,816 99.4% 88d 163d 320d
Immunology IM 3,787 99.6% 104d 232d 158d
Hematology HE 3,293 99.7% 112d 164d 394d
Toxicology TX 3,026 99.7% 86d 94d 284d
Pathology PA 1,106 97.9% 75d 212d 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 255 days in recent submissions.

Fastest (last 2 years)
94d
3,026 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
18,280 submissions 138d avg (2y)
Cardiovascular
18,086 submissions 150d avg (2y)
Orthopedic
17,930 submissions 117d avg (2y)
General Hospital
17,781 submissions 160d avg (2y)
Radiology
15,618 submissions 147d avg (2y)
Chemistry
13,225 submissions 196d avg (2y)
Dental
12,604 submissions 154d avg (2y)
Gastroenterology & Urology
9,878 submissions 154d avg (2y)
Anesthesiology
8,990 submissions 212d avg (2y)
Microbiology
7,061 submissions 151d avg (2y)
Neurology
6,290 submissions 153d avg (2y)
Physical Medicine
5,464 submissions 148d avg (2y)
Ophthalmic
5,106 submissions 167d avg (2y)
Obstetrics & Gynecology
4,501 submissions 167d avg (2y)
Ear, Nose, Throat
3,816 submissions 163d avg (2y)
Immunology
3,787 submissions 232d avg (2y)
Hematology
3,293 submissions 164d avg (2y)
Toxicology
3,026 submissions 94d avg (2y)
Pathology
1,106 submissions 212d 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 94 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 .