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FDA 510(k)

Cassette Autoclave (ACA5)

K-Number: K250164 · 2025-08-14

ApplicantGuangzhou Ajax Medical Equipment Co., Ltd.
Decision Date2025-08-14
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cassette Autoclave (ACA5) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K250164. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cassette Autoclave (ACA5)?

Cassette Autoclave (ACA5) is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K250164.

When did Cassette Autoclave (ACA5) receive FDA 510(k) clearance?

Cassette Autoclave (ACA5) received FDA 510(k) clearance on 2025-08-14, under 510(k) number K250164.

Who is the listed applicant for Cassette Autoclave (ACA5)?

The FDA 510(k) record lists Guangzhou Ajax Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cassette Autoclave (ACA5)?

The FDA product code for Cassette Autoclave (ACA5) is FLE.

Other records listing Guangzhou Ajax Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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