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FDA 510(k)

Oxygen Concentrator (J10A)

K-Number: K251534 · 2025-12-29

ApplicantFoshan Kycare Medical Equipment Co., Ltd.
Decision Date2025-12-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Oxygen Concentrator (J10A) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Kycare Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-12-29 under 510(k) number K251534. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oxygen Concentrator (J10A)?

Oxygen Concentrator (J10A) is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Foshan Kycare Medical Equipment Co., Ltd.. The 510(k) number is K251534.

When did Oxygen Concentrator (J10A) receive FDA 510(k) clearance?

Oxygen Concentrator (J10A) received FDA 510(k) clearance on 2025-12-29, under 510(k) number K251534.

Who is the listed applicant for Oxygen Concentrator (J10A)?

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

What is the FDA product code for Oxygen Concentrator (J10A)?

The FDA product code for Oxygen Concentrator (J10A) is CAW.

Other records listing Foshan Kycare 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.

K251607Oxygen Concentrator (J5A)

Related Devices (Code: CAW)

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.

K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLCK252616Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd.

Official Source

View on FDA Database →

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

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