Get predicate device for given 510(k) clearance

[fumoboy007]

A device can be “cleared” by the FDA by demonstrating that it is “substantially equivalent” to a “predicate device”, which is a previously cleared or approved device. Does the current API support getting the predicate device for a given 510(k) clearance?

[dkrylovsb]

Not at this time, unfortunately.

[fumoboy007]

Thanks for confirming, @dkrylovsb! This GitHub issue is a feature request then. 😊

[wcedmisten]

@fumoboy007 I've been scraping PDFs from the FDA's website and using OCR to find the predicates. This approach is not 100% accurate, so an official source would be better, but if you need this information, check out my repo:

https://github.com/wcedmisten/fda-510k-analysis

I also made a website for searching this info if it's helpful: 510k.fyi

Let me know if you have any questions!