Cassette Autoclave (ACA5)

FDA 510(k) K250164 · Guangzhou Ajax Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK250164

Submission

Device name
Cassette Autoclave (ACA5)
Applicant
Guangzhou Ajax Medical Equipment Co., Ltd.
Guangzhou, CN
Received
January 21, 2025
Decision date
August 14, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLE – Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Specialty
General Hospital

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Questions and answers

When was Cassette Autoclave (ACA5) cleared by the FDA?

Cassette Autoclave (ACA5) (K250164) received a 510(k) decision of Substantially Equivalent on August 14, 2025, 205 days after the submission was received.

What is the product code of K250164?

The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.