The FDA 510(k) database lists every premarket notification the FDA has cleared or decided, with the PMA and De Novo databases covering the other routes to market. Here is how to search all three, what the results can and cannot tell you, and how ClinicaLister connects each submission to its device identifiers, safety records and clinical trials.
A 510(k) is a premarket submission in which a manufacturer shows the FDA that a new device is as safe and effective as — substantially equivalent to — a device already legally on the market, called the predicate. Domestic manufacturers, specification developers, some repackagers and relabelers, and foreign manufacturers must submit one before marketing most moderate-risk devices. Each submission gets a K number (for example K203456).
Devices that are not substantially equivalent take a different route. Higher-risk devices need premarket approval (PMA), which requires the FDA to review evidence of safety and effectiveness, usually including clinical data; later changes are filed as PMA supplements. Novel lower-risk devices with no predicate can request De Novo classification, which, once granted, can itself become a predicate for future 510(k)s.
Together these databases answer the core questions in device regulatory and competitive work: who cleared what, when, through which pathway, under which product code and review panel, and which predicate it leaned on.
The FDA runs separate search pages for 510(k)s, PMAs and De Novo requests. openFDA offers the 510(k) and PMA records as a free API and bulk downloads.
On the FDA 510(k) page, search by 510(k) number, applicant name, device name or product code, and filter by submission type (Traditional, Special, Abbreviated), review panel, decision, decision date range, third-party review, combination products and whether clinical trials were part of the submission.
Each record shows the applicant, product code, regulation number, decision and date. Most link to a 510(k) summary or statement — the PDF that names the predicate device and describes the testing behind the clearance.
The PMA database searches by applicant, device, product code, PMA number, decision date, advisory committee and supplement type — choose "Originals Only" to skip the supplements. The De Novo database searches by De Novo number, device name, requester, panel and decision date.
The three-letter product code ties a device to its classification (class I, II or III, regulation and review panel). Searching any database by product code is the quickest way to list every competitor in a device category.
Query api.fda.gov/device/510k.json or /device/pma.json, for example search=product_code:DXY. Each call returns up to 1,000 records and skip goes to 25,000; without an API key you get 1,000 requests a day per IP, with a free key 120,000. Full bulk files are also available for download.
510(k) clearances and PMAs are held in one table, with each PMA collapsed to one row per PMA number (the latest supplement wins), so a company's devices read as a list of products rather than a list of filings.
Submissions are joined to their GUDID device identifiers by submission number and to the FDA product-code classification. Adverse event reports and recalls are matched by device and product code where possible.
Device–trial links are made only where the submission's applicant matches the trial's lead sponsor, then reviewed, and every link carries a confidence score and its provenance. That is stricter than a name match, so it covers a minority of device trials — but the links it makes are defensible.
When a device linked to a trial you follow changes in the FDA data, the change appears in the in-app Monitoring view alongside trial changes.
The ClinicaLister MCP server lets Claude and other assistants search devices, open a device overview and map a device landscape by product code — without writing openFDA queries.
175,900+
510(k) submissions
1,700+
PMAs (one row per PMA number)
Daily
sync from the openFDA bulk files
5.1M+
GUDID device identifiers to join against
Counts measured on the ClinicaLister platform database, August–September 2026. ClinicaLister holds the full openFDA 510(k) file. De Novo decisions appear only where they are present in that file; there is no separate De Novo feed.
A 510(k) shows a new device is substantially equivalent to a legally marketed predicate. A PMA is the FDA's approval route for higher-risk devices and requires evidence of safety and effectiveness. De Novo is the route for novel low-to-moderate-risk devices that have no predicate.
Open the record in the FDA 510(k) database and read the linked 510(k) summary or statement. The predicate is named there; it is not a searchable field in the database itself.
Yes. openFDA publishes 510(k) and PMA records at api.fda.gov/device/510k.json and /device/pma.json, free, with optional API keys for higher daily limits. ClinicaLister does not offer an API; its programmatic access is through the MCP server for AI assistants.
Look up the product code in the FDA classification database, then search the 510(k), PMA and De Novo databases by that code. In ClinicaLister, a device landscape by product code returns them in one view.
Only the De Novo numbers that appear in openFDA's 510(k) file. For a complete De Novo list, use the FDA De Novo database.
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