Using the api for the 510(k) database in openfda, I can search the statement_or_summary field and find all the rows (i.e. devices) with summaries. But in the download, the api just produces the string "Summary" in that field. In the actual FDA database, that string includes a hyperlink to a pdf document in FDA's database that is the actual "Summary." I want to download the actual links so I can consult the summary itself. How do I download the links to the pdf documents. Those summaries are rich in information.

  • Did you ever find a solution that was useful to you? I have attempted to create links to each of the PDFs where the API returns statement_or_summary returns 'Summary' but there are a lot of missing entries on the part of the FDA.
    – castis
    Mar 17, 2021 at 21:08
  • I went back 10 years doing that, and I probably got at least 90%. There certainly were missing links, but over just that tenure, I didn’t think it was too bad. Mar 18, 2021 at 23:38
  • I think there are many missing PDFs in the 510(k) Premarket Notification database, see also graph here.
    – captcoma
    Dec 18, 2022 at 22:02

1 Answer 1


openFDA gets its 510(k) data from the 510(k) downloadable files made available by the FDA. As described on the File Layout for Releasable 510(k)s page, statement_or_summary contains either "SUMMARY" or "STATEMENT". SUMMARY indicates that a summary of safety and effectiveness information is available from FDA. STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant.

It appears the hyperlink you're looking for is missing from the downloadable 510(k) files and therefore is unavailable in openFDA as well. Unfortunately, at this point you would have to look for other resources to obtain the said hyperlink. Sorry about the inconvenience.

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