Question 1

What does the 510(k) extractor read?

Accepted Answer

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number, the clearance type (Traditional, Abbreviated, or Special), and the submission status (Cleared, Pending, Withdrawn).

Question 2

How are the predicate device and equivalence captured?

Accepted Answer

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.

Question 3

Which submitter and manufacturer fields come out?

Accepted Answer

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.

Question 4

Are standards and performance tests returned as tables?

Accepted Answer

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.

Question 5

Which references does it follow, and what are the limits?

Accepted Answer

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.

510(k) Submission Extractor

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