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FDA 510(k)

DeVilbiss 5 Liter Oxygen Concentrator (555)

K-Number: K253549 · 2026-03-26

ApplicantDevilbiss Healthcare, LLC
Decision Date2026-03-26
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DeVilbiss 5 Liter Oxygen Concentrator (555) is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K253549. 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 DeVilbiss 5 Liter Oxygen Concentrator (555)?

DeVilbiss 5 Liter Oxygen Concentrator (555) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K253549.

When did DeVilbiss 5 Liter Oxygen Concentrator (555) receive FDA 510(k) clearance?

DeVilbiss 5 Liter Oxygen Concentrator (555) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K253549.

Who is the listed applicant for DeVilbiss 5 Liter Oxygen Concentrator (555)?

The FDA 510(k) record lists Devilbiss Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeVilbiss 5 Liter Oxygen Concentrator (555)?

The FDA product code for DeVilbiss 5 Liter Oxygen Concentrator (555) is CAW.

Other records listing Devilbiss Healthcare, LLC 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.

K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorK152810DeVilbiss DV6WM Wireless Modem

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, LLCK251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.K252616Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd.

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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