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CATEGORY: CLASSIFICATION
Predicate Device
A legally marketed device to which a new device is compared in a 510(k) submission to establish substantial equivalence. The predicate must have the same intended use and similar technological characteristics.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
A predicate is the legally marketed device used to argue substantial equivalence in a US 510(k). Without a suitable predicate, consider De Novo.
PROCESS / STEPS
- Search cleared devices by product code and intended use.
- Compare indications, technology, and performance needs in an SE matrix.
- Document why differences do not raise new safety/effectiveness questions.
- Support residual gaps with testing or limited clinical data if needed.
EXAMPLES
- Using a cleared infusion pump as predicate for a modified pump with the same intended use.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Predicate Device across 27 authorities in real time.
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