Cleared Traditional

K955549 - OXLIFE OXYGEN CONCENTRATORS

K955549 is an FDA 510(k) clearance for OXLIFE OXYGEN CONCENTRATORS, manufactured by Oxlife, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K955549 · Oxlife, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
101d
Days
Class 2
Risk

K955549 is an FDA 510(k) clearance for the OXLIFE OXYGEN CONCENTRATORS. 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 Oxlife, Inc. (Cape Coral, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 101 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.

FDA 510(k) Submission Details - K955549

510(k) Number K955549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date March 15, 1996
Days to Decision 101 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
39d faster than avg
Panel avg: 140d · This submission: 101d
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 234
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K955549.
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K960309 · Airsep Corp. · Feb 1997
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042 · Sim Italia S.R.L. · Nov 1996
EMOX
K954506 · Medtrak Intl., Inc. · Apr 1996
SUN MODEL OA 3000 OXYGEN ANALYZER
K952941 · Sun Medical Equipment, Inc. · Jan 1996
WESTMED CONDESATE COLLECTION TRAP
K954271 · Westmed Intl. · Dec 1995
5 LPM OXYGEN CONCENTRATOR
K953815 · Devilbiss Health Care, Inc. · Nov 1995
K955549 · OXLIFE OXYGEN CONCENTRATORS
Download PDF FDA Summary Oxlife, Inc.