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I have a question concerning the API dataset for 510(k)s - I noticed that the API data does not incorporate the "subsequent product code" data that is available when searching through the 510(k) database available on accessdata.fda.gov. This applies to 510(k)s that leverage more than 1 product code.

This is resulting in some significant differences in the data that I am seeking to pull from the API. As an example, if I want to pull all of the traditional 510(k) clearances from 2018 to present that utilized product code HRX, I receive 34 results via the API, but if I run the same search through the accessdata.fda.gov, I receive 50 results.

I emailed [email protected] about this a couple weeks ago but have not yet received a response. Is this problem only able to be resolved by changing the API data? Who can I contact to see if this aspect of the API can be changed?

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  • We have created an internal ticket to look at the issue you described and will be back in touch shortly. Oct 17, 2023 at 13:24

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Unfortunately, the Subsequent Product Code field is not yet available in the 510K downloadable data files, which are used by openFDA to build its 510K API endpoint. There is not much we can do at this point; but once the FDA does make that field available, we can add to openFDA relatively quickly as well. We will follow up once that happens.

Thank you for bringing this to our attention.

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