Cassette Autoclave (ACA5)— 510(k) K250164

Name: FDA 510(k) clearance K250164
Creator: U.S. Food and Drug Administration
Published: 2025-08-14

Substantially Equivalent

Guangzhou Ajax Medical Equipment Co., Ltd.

FDA 510(k) clearance K250164 for Cassette Autoclave (ACA5), Substantially Equivalent on 2025-08-14. Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2025-01-21
Decision date: 2025-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.