Cleared Traditional

K012037 - HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

K012037 is an FDA 510(k) clearance for HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009, 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 202-day FDA review.

K012037 · Airsep Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
202d
Days
Class 2
Risk

K012037 is an FDA 510(k) clearance for the HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009. 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 January 17, 2002 after a review of 202 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 Airsep Corp. devices

FDA 510(k) Submission Details - K012037

510(k) Number K012037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date January 17, 2002
Days to Decision 202 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 140d · This submission: 202d
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 214
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K012037.
P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
K020362 · On Site Gas Systems, Inc. · Feb 2002
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
K013223 · Litton Systems, Inc. · Feb 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · Merits Health Products Co., Ltd. · Feb 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · On Site Gas Systems, Inc. · Jan 2002
HOME-AWAY SYSTEM
K004047 · In-X Corp. · Dec 2001
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001