Medical device predicate search

Enter a 510(k) number. We pull its FDA record live from openFDA, then surface earlier clearances in the same product code as candidates for you to investigate as potential predicates. Free, no signup.

What this tool is not. Earlier clearances in the same product code are candidates to investigate, not determinations. An actual predicate relationship is established in the 510(k) summary on file with FDA for the specific submission. Verify any predicate claim against the official summary before relying on it.

Data: U.S. FDA via openFDA (public domain). Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Full terms: open.fda.gov/terms. Not regulatory advice.