← 所有术语
类别: CLASSIFICATION
等同器械
在510(k)提交中用于与新器械进行比较以建立实质等效性的已合法上市器械。等同器械必须具有相同的预期用途和相似的技术特征。
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 等同器械 across 27 authorities in real time.
START FREE →