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FDA 510(k)

Portable Oxygen Concentrator

K-Number: K252399 · 2026-06-17

ApplicantHonsun (Nantong) Co., Ltd.
Decision Date2026-06-17
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K252399. 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 Portable Oxygen Concentrator?

Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K252399.

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

Portable Oxygen Concentrator received FDA 510(k) clearance on 2026-06-17, under 510(k) number K252399.

Who is the listed applicant for Portable Oxygen Concentrator?

The FDA 510(k) record lists Honsun (Nantong) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Oxygen Concentrator?

The FDA product code for Portable Oxygen Concentrator is CAW.

Other records listing Honsun (Nantong) Co., Ltd. as applicant

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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.

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, LLCK251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.K252616Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd.K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology 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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