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FDA 510(k)

Portable Oxygen Concentrator (PO1 5B, PO1 6B)

K-Number: K260171 · 2026-08-14

ApplicantBMC Medical Co., Ltd.
Decision Date2026-08-14
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable Oxygen Concentrator (PO1 5B, PO1 6B) is the device name listed in this FDA 510(k) record. The listed applicant is BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260171. 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 (PO1 5B, PO1 6B)?

Portable Oxygen Concentrator (PO1 5B, PO1 6B) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K260171.

When did Portable Oxygen Concentrator (PO1 5B, PO1 6B) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (PO1 5B, PO1 6B) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260171.

Who is the listed applicant for Portable Oxygen Concentrator (PO1 5B, PO1 6B)?

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

What is the FDA product code for Portable Oxygen Concentrator (PO1 5B, PO1 6B)?

The FDA product code for Portable Oxygen Concentrator (PO1 5B, PO1 6B) is CAW.

Other records listing BMC Medical 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.

K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)K242935Respiration Data Management Software (PAP Link PC)K213169BPAP SystemK211155Auto CPAP SystemK163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

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.

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.K252616Portable 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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