K250164 is an FDA 510(k) clearance for the Cassette Autoclave (ACA5). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 14, 2025, 205 days after receiving the submission on January 21, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K250164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | August 14, 2025 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |