I have a question regarding the openFDA 510k data:

According to the File Layout for Releasable 510(k)s the statement_or_summary entry gives following information:

SUMMARY indicates that a summary of safety and effectiveness information is available from FDA

However, for many devices with a summary entry in statement_or_summary, no summary document is available on the 510(k) Premarket Notification Database: e.g., for K990380

Where are these summary documents available?

1 Answer 1


Unfortunately, the FDA 510(k) Premarket Notification database misses many PDFs for items that have a statement or summary entry in the openFDA 510k data file.

I think in many cases with a missing PDF there is most likely no electronic copy available. If someone really needs these files, they could probably be recovered via a Freedom of Information Act request (FOIA).

Here the data for the /device/510k data downloaded on 2022-11-16

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