About 510k.fyi

Hello! My name is William Edmisten, and I'm the software engineer who built 510k.fyi. You can read more about me on my blog.

I built 510k.fyi to help consumers, device manufacturers, and the FDA better understand the predicate device ancestry of devices cleared through the 510k process.

As of February 2024, the FDA's 510k database does not directly show the predicates used for each device. The only way to find the predicates for 510k is to manually examine the PDF summary of each 510k application. This makes any systematic review of predicate device ancestry difficult.

I collected all of the available 510k PDF summaries and used OCR to find the predicates mentioned for each application, in order to simplify the data, and help show the relationship between recalled devices and currently marketed ones.

Please submit any feedback to [email protected]