Extract the K-number, device name, classification, product code, predicate device, and substantial-equivalence decision from an FDA 510(k) submission PDF.
The full guide: Predicate device and K-number from an FDA 510(k)
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The 510(k) submission number (K-number), the submission and decision dates, the device name, the device classification (Class I, II, or III), the three-letter product code, the 21 CFR regulation number, the clearance type (Traditional, Abbreviated, or Special), and the submission status (Cleared, Pending, Withdrawn).
The predicate device K-number, the substantial-equivalence boolean, and the decision code (such as SESE for substantially equivalent) come back as fields, and a predicate devices table returns each predicate K-number, device name, and applicant.
The submitter name, address, and contact person, the manufacturer name and address, the advisory committee (review panel), the intended use and device description, and the expedited-review and third-party-review flags, plus the applicant country code.
Yes. An applicable standards table returns each standard number, title, and compliance status; a performance tests table returns each test name, method, and result; and a device components table returns each component name, material, and function.
The field labels follow the openFDA device/510(k) clearance references. PDF only, up to 10MB and 100 pages. The submission is processed via the Talonic API for extraction, is not retained for training, and is not shared.
The tool reads a single document. The platform reads the whole estate once and keeps it queryable — the same engine, with a memory.
See document data extraction if you run this for clinical and billing teams, or the extraction API if you are building it in.