Cleared Traditional

K952037 - 3 LPM OXYGEN CONCENTRATOR

K952037 is an FDA 510(k) clearance for 3 LPM OXYGEN CONCENTRATOR, manufactured by Devilbiss Health Care, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K952037 · Devilbiss Health Care, Inc. · Anesthesiology device
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Sep 1995
Decision
128d
Days
Class 2
Risk

K952037 is an FDA 510(k) clearance for the 3 LPM OXYGEN CONCENTRATOR. 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 Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 128 days - within the typical 510(k) review window.

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 Health Care, Inc. devices

FDA 510(k) Submission Details - K952037

510(k) Number K952037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date September 06, 1995
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 133
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K952037.
5 LPM OXYGEN CONCENTRATOR
K953815 · Devilbiss Health Care, Inc. · Nov 1995
ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
K951882 · Airsep Corp. · Oct 1995
HUMIDIFIER & ACCESSORIES
K953949 · Fisher & Paykel Electronics , Ltd. · Oct 1995
H-500 ALLIANCE OXYGEN CONCENTRATOR
K942357 · Healthdyne, Inc. · May 1994
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · Invacare Corp. · Aug 1993
KEYSTONE CONCENTRATOR, MODEL PV5L
K924152 · Devilbiss Health Care, Inc. · Jun 1993