Cleared Traditional

K801523 - MODEL 379 WXYGEN CONCENTRATOR

K801523 is an FDA 510(k) clearance for MODEL 379 WXYGEN CONCENTRATOR, manufactured by Stanley Aviation Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K801523 · Stanley Aviation Corp. · Anesthesiology device
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Jul 1980
Decision
13d
Days
Class 2
Risk

K801523 is an FDA 510(k) clearance for the MODEL 379 WXYGEN 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 Stanley Aviation Corp. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 13 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.

FDA 510(k) Submission Details - K801523

510(k) Number K801523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1980
Decision Date July 14, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
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 K801523.
MODEL #6200 OXYGEN CONCENTRATOR
K822889 · Hudson Oxygen Therapy Sales Co. · Oct 1982
MODEL 6200 OXYGEN CONCENTRATOR
K813320 · Hudson Oxygen Therapy Sales Co. · Dec 1981
MINI O2
K812513 · Mountain Medical Equipment, Inc. · Sep 1981
LINDE OXYGEN CONCENTRATOR LOC-II
K791437 · Union Carbide Corp. · Sep 1979
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · Union Carbide Corp. · Jun 1979
MODEL 290 OXYGEN RICH AIR SUPPLY UNIT
K780862 · The John Bunn Co. · Aug 1978
K801523 · MODEL 379 WXYGEN CONCENTRATOR
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