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KATEGORIE: CLASSIFICATION
Referenzprodukt (Prädikatsgerät)
Ein legal vermarktetes Gerät, mit dem ein neues Gerät in einem 510(k)-Antrag verglichen wird, um wesentliche Gleichwertigkeit nachzuweisen.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 Referenzprodukt (Prädikatsgerät) across 27 authorities in real time.
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