Cleared Traditional

K013223 - PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)

K013223 is an FDA 510(k) clearance for PATIENT VENTILATION OXYGEN CONCENTRATIN..., manufactured by Litton Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K013223 · Litton Systems, Inc. · Anesthesiology device
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Feb 2002
Decision
137d
Days
Class 2
Risk

K013223 is an FDA 510(k) clearance for the PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS). 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 Litton Systems, Inc. (Davenport, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 137 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 Litton Systems, Inc. devices

FDA 510(k) Submission Details - K013223

510(k) Number K013223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date February 11, 2002
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 164
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K013223.
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · Invacare Corp. · Jul 2002
LIFESTYLE OXYGEN CONCENTRATOR
K020324 · Airsep Corp. · Mar 2002
MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K014301 · Merits Health Products Co., Ltd. · Feb 2002
HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
K012037 · Airsep Corp. · Jan 2002
TOTAL O2
K013472 · Chad Therapeutics, Inc. · Nov 2001