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Predicate search

Type your product code and a few words about your device. You get the devices FDA has cleared under that code, ranked by how well their names match. It's a starting list from FDA's 510(k) database. No AI, and nothing you type is saved. Don't know your product code? Use the classification lookup first.

What this list is, and isn't

It ranks by the words in each device's name. It doesn't read any 510(k) summary, so it knows nothing about intended use or technology, which are what decide substantial equivalence.
De Novo decisions under the code are included and labelled: a device granted De Novo can be a predicate too.
Choosing a predicate is your decision. Confirm it with FDA through a Pre-Submission, or with a qualified regulatory professional.

In Regulatory Copilot, the screened search reads each candidate's 510(k) summary and compares intended use and technology, with the reasons for every match. Join the founding cohort for an account.