A quick guide to the 510(k) Clearances API

If you have never hit device/510k.json before, start here — we explain what comes back and how to write a basic search.

Illustration for 510(k) Clearances openFDA guide

What this endpoint does

Need 510(k) clearances data without downloading bulk files? The device/510k.json endpoint is the usual starting point. Premarket notifications demonstrating substantial equivalence.

Who uses it

Regulatory consultants and biomedical engineers query device endpoints when tracking 510(k) clearances, PMA decisions, or malfunction reports. Product descriptions vary wildly in length.

Example request

Paste this into a browser or our Explorer (swap the search term as needed):

GET https://api.fda.gov/device/510k.json?search=applicant:medtronic&limit=5

You should see JSON with meta.results.total telling you how many matches exist.

Searching the data

Start with search=applicant:medtronic in our Explorer or your own HTTP client. Each endpoint documents its own field list on open.fda.gov. Common knobs: limit (how many rows), skip (offset for paging), sort (field:asc or field:desc), and count (aggregate unique values).

Tips that save time

openFDA timestamps and text fields are not always pretty. Trim your expectations for spelling and missing values.

  • limit — usually capped at 1,000 per call
  • skip — walk through large result sets
  • count=some_field.exact — quick frequency tables

Before you rely on this data

openFDA Explorer is an independent website. We are not affiliated with, endorsed by, or operated by the U.S. Food and Drug Administration (FDA).

FDA public data is useful for research and general interest. It is not medical advice. Talk to a qualified healthcare professional about your health. openFDA data may be incomplete or reported voluntarily — treat it as a starting point, not a verdict.

Try it in the Explorer

Run a live search on device/510k.json — we forward the query to openFDA and show you the JSON.

Open in Explorer