Cleared Traditional

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

K250805 · Devilbiss Healthcare, LLC · Anesthesiology
Dec 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K250805 is an FDA 510(k) clearance for the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on December 9, 2025, 267 days after receiving the submission on March 17, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K250805 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2025
Decision Date December 09, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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