I want to know how to search the PDF files with a search term.

Most 510K records have the value "Summary" stored in the Summary field.

How can one search the PDF files attached to the summary and run query on that pdf file?

This search does NOT work -> https://api.fda.gov/device/510k.json?search=limit=1&statement_or_summary:%22cardiac%22

But this document DOES contain the work cardiac in it https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140916.pdf

Please help.


1 Answer 1


Most 510K records have the value "Summary" stored in the Summary field.

There is no such thing as the "Summary" field.

A statement or summary can be provided per 21 CFR 807.3(n) and (o). A 510(k) summary, submitted under section 513(i) of the act, of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness. The 510(k) Statement is a statement, made under section 513(i) of the act, asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent.

Thus, in your example, "Summary" is a title, and "Liquichek Cardiac Troponins Control" is a subtitle.

API response does not contain the value of this subtitle.

The value of the statement_or_summary field is a type of document:

  • "statement" (68000 items),
  • "summary" (25000 items),
  • empty record (55 000 items).

I think, in many cases, the value of subtitle should be similar to the value of the device_name field.
Also, if you don’t specify a field to search, the API will search in every field.

  • Unfortunately, for many items with a entry in statement_or_summary there is no PDF available from the FDA (see also here)
    – captcoma
    Commented Dec 18, 2022 at 22:19

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