FDA 510(k) database search

A 510(k) is the premarket notification a manufacturer files to show FDA that a new medical device is substantially equivalent to one already legally marketed (the predicate). This free database search covers 175,734 cleared 510(k)s from 1976 to September 19, 2026, from openFDA: search by K number, three-letter product code, company or device name. FDA cleared 3,289 510(k)s in the 12 months to September 19, 2026, with a median of 130 days from receipt to decision.

510(k) clearances at a glance

How to read the results

• 510(k) number: K plus six digits; the first two are the year FDA received it. Links to the FDA record.
• Applicant: the company that submitted the 510(k), as FDA records it.
• Product code: the three-letter FDA device type, linking to its clearance history and recalls.
• Decision date and review days: calendar days from FDA receipt to decision, including time on hold.
• Type: Traditional, Special (changes to the sponsor's own device) or Abbreviated (relies on guidance or standards).

The 20 most recent 510(k) clearances

How long do these reviews take by panel and submission type? See FDA 510(k) review times.

Browse by review panel

• Anesthesiology
• Clinical Chemistry
• Cardiovascular
• Dental
• Ear, Nose and Throat
• Gastroenterology and Urology
• Hematology
• General Hospital
• Immunology
• Medical Genetics
• Microbiology
• Neurology
• Obstetrics and Gynecology
• Ophthalmic
• Orthopedic
• Pathology
• Physical Medicine
• Radiology
• General and Plastic Surgery
• Clinical Toxicology

Frequently asked questions

What is a 510(k)?

A 510(k), or premarket notification, is the submission a device maker sends FDA at least 90 days before marketing a Class I, II or (rarely) III device that does not need a PMA. It must show the device is as safe and effective as a legally marketed predicate device. FDA either clears it (substantially equivalent) or finds it not substantially equivalent. openFDA lists 175,734 cleared 510(k)s since 1976.

How long does a 510(k) take?

In the 12 months to September 19, 2026, the median cleared 510(k) took 130 calendar days from FDA receipt to decision, and a quarter took longer than 224 days. That clock includes time on hold waiting for the sponsor's answers; FDA's MDUFA goal of 90 review days excludes it. See the full breakdown by panel and submission type on the 510(k) review times page.

What is a K number?

The K number is FDA's identifier for a 510(k): the letter K followed by six digits, e.g. K253166. The first two digits are the year FDA received the submission and the rest is a sequence number. De Novo requests use DEN numbers instead. Every K number in the search links to its FDA record.

What is the difference between a 510(k), PMA and De Novo?

A 510(k) clears a device by comparison with a predicate already on the market; most Class II devices take this route. A PMA (premarket approval) is required for most Class III devices and must prove safety and effectiveness with clinical evidence. A De Novo request classifies a novel low-to-moderate risk device that has no predicate, and the granted device can then serve as a predicate. openFDA lists 175,734 cleared 510(k)s, 1,749 PMA applications and 489 granted De Novo requests.

Source: openFDA device 510(k) data (public domain), data as of September 19, 2026. FDA's own search: Premarket Notification database. Not regulatory advice.

FDA product code lookup · 510(k) review times