類別: REGULATORY PATHWAYS

510(k)許可

向FDA提交的上市前申請，證明醫療器材與已上市的等同器材實質等效。510(k)是II類器材進入美國市場最常見的途徑。

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.

RELATED GUIDES & TOOLS

SOURCES

FDA Premarket Notification 510(k) ↗

Track regulatory signals related to 510(k)許可 across 27 authorities in real time.

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