510(k)-Zulassung
Ein Antrag an die FDA, der nachweist, dass ein Medizinprodukt einem bereits zugelassenen Referenzprodukt wesentlich gleichwertig ist. Der 510(k)-Weg ist der häufigste Marktzugang für Klasse-II-Produkte in den USA.
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
Use the 510(k) pathway when marketing a Class II device (and some Class I/III devices with product-code exceptions) in the United States and you can identify a suitable predicate. If no predicate exists, evaluate De Novo instead of forcing a weak 510(k).
PROCESS / STEPS
- Confirm product code and device class via the FDA product classification database.
- Select one or more predicates with the same intended use and comparable technology.
- Build a substantial-equivalence matrix: intended use, indications, technological characteristics, performance testing.
- Complete bench, biocompatibility, software (if SaMD/SiMD), and clinical data only if required to close SE gaps.
- Submit eSTAR/eCopy package; respond to AI requests within FDA timelines; receive clearance letter (SE) or NSE.
EXAMPLES
- Infusion pumps, many imaging accessories, and powered surgical tools commonly use 510(k).
- A modified version of a cleared device may still need a new 510(k) if changes affect safety or effectiveness.
COMMON MISTAKES
- Choosing a predicate with a different intended use (often leads to NSE).
- Ignoring cumulative design changes that together require a new submission.
- Under-documenting software or cybersecurity for connected devices.
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SOURCES
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