Cleared Traditional

Cassette Autoclave (ACA5)

K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · General Hospital

Aug 2025

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K250164 is an FDA 510(k) clearance for the Cassette Autoclave (ACA5), 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 review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K250164 FDA.gov
FDA Decision	Cleared 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