October 2026 FDA 510(k) clearances

139 US 510(k) clearances in October 2026. October 2025: 150. 127 companies, 17 review panels and 32 states. FDA data through October 30, 2026.

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Top review panels

Review panel	Clearances
Orthopedic	28
Cardiovascular	27
Microbiology	14
Radiology	12
Gastroenterology, Urology	9
General, Plastic Surgery	9
Neurology	8
Dental	7
General Hospital	6
Clinical Chemistry	5
Anesthesiology	3
Obstetrics/Gynecology	3
Hematology	2
Immunology	2
Ophthalmic	2
Pathology	1
Physical Medicine	1

Top states

State	Clearances
California	34
Pennsylvania	11
Florida	10
Minnesota	8
Massachusetts	7
Colorado	6
Ohio	6
New York	5
Texas	5
Georgia	4
Utah	4
Indiana	3
North Carolina	3
Nevada	3
Tennessee	3
Arizona	2
Illinois	2
Maryland	2
Maine	2
Michigan	2
New Hampshire	2
New Jersey	2
Oklahoma	2
South Carolina	2
Wisconsin	2
Iowa	1
Idaho	1
Kansas	1
Missouri	1
Oregon	1
Virginia	1
Wyoming	1

Top companies

The 15 applicants with the most clearances in October 2026. A tie breaks on the applicant name, A to Z.

Company	Clearances
Cepheid	3
Roche Diagnostics	3
Arthrex, Inc.	2
Beckman Coulter, Inc.	2
Foreo, Inc.	2
Intuitive Surgical, Inc.	2
Maine Molecular Quality Controls, Inc.	2
SeaSpine Orthopedics Corporation	2
Smith & Nephew, Inc.	2
Steris	2
Aesculap, Inc.	1
Airgas Therapeutics, LLC	1
Alembic, LLC	1
Allwin Medical Devices, Inc.	1
Alphatec Spine, Inc.	1

Methodology

A clearance is counted when its decision date falls in October 2026, the FDA decision is substantially equivalent, the applicant state is a US state, the record has a review panel, and the K number is in Whimbrel's corpus. Company, device, state, product code and review panel are the openFDA fields for that K number. The file behind this page runs from August 1, 2025 through October 30, 2026.

Sources: openFDA device 510(k) API, openFDA license, FDA 510(k) database, and the FDA page on Premarket Notification 510(k).

Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.

FAQ

What is counted?

US 510(k) clearances with a decision date in October 2026. The FDA decision is substantially equivalent, the state is a US state, and the K number is in Whimbrel's records.

Where does the count come from?

openFDA and the FDA 510(k) database. The methodology section links both.

When does a new month get a page?

After that month has ended, and the FDA data in Whimbrel's corpus covers it.

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