Class Class II
Cassette Autoclave (ACA5) (K250164)
Description
Cassette Autoclave (ACA5) by Guangzhou Ajax Medical Equipment Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250164
Clearance Date2025-08-14
Clearance TypeTraditional
Product CodeFLE
Regulation Number880.6880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250164
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Cassette Autoclave (ACA5) (K250164) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210279 | Enbio S | Enbio Group AG | 2021 |
Trace the full predicate network for K250164
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.