# K250164: Cassette Autoclave (ACA5)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
- Decided: Aug 14, 2025 after 205 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190062 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210279: Enbio S, Enbio Group AG (2021) Summary page 5.

## Indications for use
The Cassette Autoclave (ACA5 is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. Please refer to below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.: 1) Program Name: 134 ℃ Load Description: Solid objects small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature: 134 ℃273℉ Sterilization Time: 4 minutes Drying Time: 60 minutes Load Weight: 0.9 kg 2) Program Name: 121℃ Load Description: Solid objects small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped. Sterilization Temperature: 121 ℃250℉ Sterilization Time: 30 minutes Drying Time: 60 minutes Load Weight: 0.9 kg

Source page: https://510kreport.com/device/K250164
Methodology: https://510kreport.com/methodology