Cleared Traditional

K020324 - LIFESTYLE OXYGEN CONCENTRATOR

K020324 is an FDA 510(k) clearance for LIFESTYLE OXYGEN CONCENTRATOR, manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K020324 · Airsep Corp. · Anesthesiology device
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Mar 2002
Decision
41d
Days
Class 2
Risk

K020324 is an FDA 510(k) clearance for the LIFESTYLE 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 Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Airsep Corp. devices

FDA 510(k) Submission Details - K020324

510(k) Number K020324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2002
Decision Date March 13, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 92
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K020324.
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · Invacare Corp. · Jul 2002
VENTURE HOME FILL II, MODEL IOH 200
K003939 · Invacare Corp. · Mar 2001
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088 · Puritan Bennett Corp. · Oct 1999