FDA 510(k) Database

The FDA 510(k) Premarket Notification Database is CDRH's public record of every 510(k) decision since 1976. It is the authoritative source for clearance status, K-number assignment, applicant, device trade name, product code, regulation number, decision date and decision type (SE — substantially equivalent / NSE — not substantially equivalent / withdrawal). Each record links to the 510(k) Summary (or, less commonly, the 510(k) Statement) and the clearance letter (the SE letter).

Three downstream systems sit alongside it. The Product Classification Database resolves product codes to regulation numbers, device names, classes and panel assignments. The Establishment Registration & Device Listing database confirms who is currently marketing the cleared device. The openFDA Device 510(k) API exposes the same data set programmatically (JSON, query language, no API key required for basic use).

• K-number (e.g. K241234). The unique identifier for each submission. Once you know the K-number, you have everything else.
• Applicant Name. The 510(k) holder at time of clearance — note this can be out of date if the device was sold or the company renamed.
• Device Name. The cleared trade name; partial-match strings work but try multiple variants (brand vs generic).
• Product Code. The three-letter CDRH code that defines the device generic type (e.g. LZG for an infusion pump). Predicate searches almost always start here.
• Regulation Number. The 21 CFR 862–892 citation for the device type. Useful when the same product code spans multiple regulations or you want sibling product codes.
• Decision. SE (cleared), NSE (not substantially equivalent), W (withdrawn). Filter to SE for predicate work.
• Decision Date. Use for trend analysis or to scope competitor activity in a recent window.
• Advisory Committee (Panel). The medical specialty panel (e.g. ANE for anaesthesia). Useful when you know the panel but not the product code.

The most common workflow: find your product code in the Product Classification Database, then search the 510(k) database by product code with Decision = SE, sorted by Decision Date descending. The result is every cleared device of that type in date order.

Under 21 CFR 807.92, sponsors may submit a 510(k) Summary — a structured public document that includes device description, indications for use, predicate device, summary of non-clinical and clinical testing and substantial-equivalence discussion. Summaries are published in the database and are the primary public source of substantive information about the cleared device.

Alternatively under 21 CFR 807.93 sponsors may submit a 510(k) Statement — a one-page commitment that the sponsor will, on request, provide non-confidential information about the safety and effectiveness data within 30 days. The Statement option is older and largely deprecated; current practice and FDA expectation is the Summary. When you see a Statement, you can request the underlying information by FOIA but it is slow.

Predicate selection is the most common reason to use the database. The default workflow: (1) confirm your device's product code; (2) pull the SE decisions in that product code in the last 5–10 years; (3) screen Summaries for devices with intended use and technological characteristics aligned to yours; (4) shortlist 3–5 candidate predicates; (5) review each Summary for indications-for-use language, performance-data scope, and any AI letter signals; (6) verify each candidate predicate is still legally marketed (Establishment Registration & Device Listing); (7) confirm none was withdrawn for safety reasons (a withdrawn-for-safety predicate is not eligible).

Reference devices, where applicable, follow the same workflow but with different intent. FDA does not accept a split predicate (one predicate for intended use, another for technology), but a primary predicate plus reference devices can support specific technological characteristics. Identify the reference devices from cleared sibling product codes and document their role in the predicate-comparison table.

The database is the cheapest competitive-intelligence source CDRH provides. Useful queries:

• Filter by Applicant Name to see every clearance a competitor holds and their generic-type footprint.
• Filter by Product Code + Decision Date to see how many competitors are crowding a niche year-over-year.
• Pull Summaries from competitor 510(k)s to learn their indications-for-use language, claimed advantages, technology approach and performance test scope.
• Cross-reference the FDA Recalls Database and MAUDE (Manufacturer and User Facility Device Experience) to see post-market quality signal on competitor devices.
• Combine with the openFDA Device 510(k) API to build a competitor-clearance alert (new SE in a product code = competitor entry).

Three limits matter. First, the database does not show the full submission — only the Summary or Statement plus the clearance letter. Trade secrets and confidential commercial information stay confidential under FOIA exemption 4. Second, the database does not show withdrawn or RTA'd submissions; only decided submissions appear. Third, the database does not flag whether a cleared device is still being marketed — a 1992 clearance in the database might cover a device discontinued in 2002.

For a complete picture, combine the 510(k) database with: Product Classification (regulation context), Establishment Registration & Device Listing (current marketing status), MAUDE (post-market safety signal), Recalls (Class I/II/III recall actions), and openFDA Device APIs (programmatic access).

openFDA exposes the 510(k) database as a JSON API at /device/510k.json. Query by any indexed field with a Lucene-style search syntax. Example: a search for product_code:LZG AND decision_code:SE returns every infusion-pump SE decision. The API has rate limits (240 requests per minute, 1,000 per day for unauthenticated; higher with a free API key) and is appropriate for building competitor-clearance alerts, predicate-search dashboards, or import pipelines into internal regulatory-intelligence systems.

Data is refreshed weekly. A 510(k) decision typically appears in the database within 7–14 days of the SE letter. For real-time tracking of your own submissions, use FDA's CDRH Customer Collaboration Portal rather than the public database.