FDA K Number for a Medical Device: What It Is and How to Look It Up

This page describes products and general use; it is not medical advice.

A K number is the identifier FDA gives to a 510(k) premarket notification record. If a supplier or a product label quotes one, you can look it up in FDA’s public database and check what was cleared, for whom, and under which product code. Typical readers are clinic staff, procurement and quality teams, and students tracing how a device reached the U.S. market.

What is a K number on a medical device?

A K number is the 510(k) number of a premarket notification. FDA’s database describes a 510(k) as “a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device” that is not subject to premarket approval. The number identifies one submission and one FDA decision. It does not identify a model, a lot or a factory. For the pathway itself, see FDA device classification, 510(k) and PMA.

In FDA’s current public records the number is a capital K followed by six digits; for example, records decided in October 2026 carry numbers such as K262000 and K262478 (openFDA 510(k) endpoint, checked 1 November 2026). FDA’s own advice to applicants is to reference the 510(k) number in any correspondence about a 510(k).

Where to find a K number

FDA tells applicants to keep the 510(k) clearance letter, which it calls the letter of substantial equivalence, with their records. The K number appears in that letter, so the most reliable route for a buyer is to ask the supplier for the number, the product code and the device name exactly as FDA lists them, rather than relying on a marketing page.

How to look up a 510(k) number

FDA’s 510(k) Premarket Notification database has a search field labelled “510K Number”. The same form can also be searched by:

• device name and applicant name;
• decision date range;
• product code, review center and panel;
• decision, and whether a predetermined change control plan was authorized or the submission was third-party reviewed.

The form can filter by submission type (Traditional, Special or Abbreviated), and results can be sorted by decision date, device name, applicant name or 510(k) number. If you only have a product name, search by device name or applicant and then match the K number the supplier gave you. The same data is available programmatically through openFDA’s 510(k) endpoint, which exposes a k_number field. Related lookups are covered in FDA registration lookup and the FDA product classification database.

Reading the record

Field in the releasable record	What it tells you
510(k) number	The identifier of the submission
Applicant	The company that submitted it; this may differ from the brand on the product
Date received, decision date	When FDA received the submission and when it decided
Decision (code)	Whether FDA found the device substantially equivalent, not substantially equivalent, or another outcome
Product code and advisory committee	The device type FDA assigned it to, and the review and classification committees
Type of 510(k) submission	Traditional, Special or Abbreviated
Summary or Statement	Summary: a summary of safety and effectiveness information is available from FDA. Statement: that information must be requested from the applicant
Third-party and expedited review flags	Whether a third party reviewed it (Y or N); expedited review (Y, N or null)
Device name	The name FDA recorded for the cleared device

Source for the table: FDA, “File layout, releasable 510(k)s”, checked 1 November 2026.

Decision codes

FDA groups decision codes into three tables: substantially equivalent, not substantially equivalent, and other. Examples from FDA’s tables: SE is substantially equivalent, SN is substantially equivalent for some indications, SU is substantially equivalent with limitations, and SK is substantially equivalent as a kit. NE is not substantially equivalent, and WD (in the other-codes table) is withdrawn by applicant. A K number whose decision is not a substantially equivalent code does not show a cleared device, so read the decision before accepting a K number as evidence.

What a K number does not tell you

• It is not an FDA approval. FDA’s wording for a favorable result is substantial equivalence, issued in a clearance letter. Premarket approval is a separate pathway.
• It does not show that the maker or distributor is registered. Establishment registration is a separate record; see FDA-registered medical devices and what “FDA certified” does and does not mean.
• FDA states that it cannot change a 510(k) after a final determination, so a K number points to the device as it was reviewed. Compare the product in front of you with the cleared device name and applicant.
• It does not replace the unique device identifier on a label; see UDI labels.

Checklist for checking a K number

1. Ask the supplier for the K number, product code and device name.
2. Search the 510(k) database by number and open the record.
3. Confirm the device name and applicant match the product and its maker.
4. Read the decision and its code, not only the existence of a record.
5. Note the decision date and whether a Summary is available from FDA or a Statement means you must ask the applicant.
6. Keep the number with your supplier file, as FDA advises applicants to keep the clearance letter.

Common mistakes

• Calling a cleared device “FDA approved”.
• Treating any record that exists as clearance without reading the decision.
• Matching only the K number and not the device name and applicant.

FAQ

What is a K number?

It is the identifier of a 510(k) premarket notification submission to FDA. In current records it is the letter K followed by six digits.

How do I do a 510(k) number lookup?

Open FDA’s 510(k) Premarket Notification database, enter the number in the “510K Number” field, and open the matching record. Check device name, applicant, product code and decision.

Sources

• FDA, 510(k) Premarket Notification database, checked 1 November 2026.
• FDA, File layout, releasable 510(k)s, checked 1 November 2026.
• FDA, 510(k) format tips, checked 1 November 2026.
• FDA, openFDA device 510(k) endpoint (data last updated 19 October 2026), checked 1 November 2026.