Cleared Traditional

K250805 - DeVilbiss PulmO2 10-Liter Oxygen Concen...

K250805 is an FDA 510(k) clearance for DeVilbiss PulmO2 10-Liter Oxygen Concen..., manufactured by Devilbiss Healthcare, LLC. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 267-day FDA review.

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

K250805 is an FDA 510(k) clearance for the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on December 9, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Devilbiss Healthcare, LLC devices

FDA 510(k) Submission Details - K250805

510(k) Number K250805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 140d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K250805.
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 2025
Portable oxygen concentrator (JLO-190P)
K252616 · Shenzhen Homed Medical Device Co., Ltd. · Dec 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · Shenzhen Harveymed Technology Co., Ltd. · Dec 2025
Oxygen Concentrator (J5A)
K251607 · Foshan Kycare Medical Equipment Co., Ltd. · Nov 2025
Portable oxygen concentrator (JAY-1000P)
K243833 · Longfian Scitech Co., Ltd. · Sep 2025
Portable oxygen concentrator (W-R1(MAX))
K250625 · Nanjing Yinuoji Medical Technology Co., Ltd. · Aug 2025