How to find, evaluate, and document predicate devices for your 510(k) submission.
Not every cleared device can serve as your predicate. FDA has specific requirements for what counts as legally marketed — and using an invalid one wastes months.
The FDA 510(k) database has 175,000+ records — but the default search interface misses a lot. Here's how to search more effectively and find predicates FDA's tool won't surface.
A single predicate often can't carry the full substantial equivalence argument. Here's when multiple predicates are appropriate — and how FDA evaluates them.
MAUDE adverse event reports can reveal post-market problems with a predicate device before you commit to it. Here's how to use FDA's adverse event database in your predicate research.
Every 510(k) predicate was itself cleared based on an earlier predicate. Tracing that lineage generation by generation can reveal risks your submission needs to address.
Finding the right predicate is the most consequential decision in a 510(k) submission. Here's the systematic approach regulatory consultants actually use.
Section 4 is where your substantial equivalence argument lives. It's the section FDA reviewers read most carefully — and the one most likely to generate Additional Information requests.
FDA's 510(k) database contains 175,000+ clearances going back to 1976. Here's how to search it strategically — not just successfully.