I can use the API to determine if a "statement_or_summary" exists. Is there a way to download the 510(k) summary documents, or get links to those documents? I am fine ignoring the documents that are missing summaries.

1 Answer 1


openFDA does not contain the actual summary or statement documents. You can determine which results have summary or statement results with the following query: https://api.fda.gov/device/510k.json?search=statement_or_summary:Summary+OR+statement_or_summary:Statement

I don't see anywhere on the FDA's 510(k) website regarding a download location for Summaries or Statements, so you may want to follow up with the FDA directly.


Violet Wren, openFDA Tech Lead

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