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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 a medical device manufactured by Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2026-03-26 under approval 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. It is manufactured by Devilbiss Healthcare, LLC. The 510(k) number is K253549.

When was DeVilbiss 5 Liter Oxygen Concentrator (555) approved by the FDA?

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

What company makes DeVilbiss 5 Liter Oxygen Concentrator (555)?

DeVilbiss 5 Liter Oxygen Concentrator (555) is manufactured by Devilbiss Healthcare, LLC.

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 Devices by Devilbiss Healthcare, LLC

K152810DeVilbiss DV6WM Wireless Modem K172648Drive DeVilbiss iGo 2 Portable Oxygen Concentrator K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Related Devices (Code: CAW)

K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. K182454O2 Concepts Oxlife Independence Model 301-0001O2 Concepts, LLC K172234Oxygen ConcentratorSysmed (China) Co., Ltd. K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityInvacare Corporation

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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