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FDA 510(k)

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

K-Number: K250625 · 2025-08-27

ApplicantNanjing Yinuoji Medical Technology Co., Ltd.
Decision Date2025-08-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Yinuoji Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K250625. 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 (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))?

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Nanjing Yinuoji Medical Technology Co., Ltd.. The 510(k) number is K250625.

When did Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) receive FDA 510(k) clearance?

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K250625.

Who is the listed applicant for Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))?

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

What is the FDA product code for Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))?

The FDA product code for Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) is CAW.

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, LLCK251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment 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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