Cleared Traditional

K791437 - LINDE OXYGEN CONCENTRATOR LOC-II

K791437 is an FDA 510(k) clearance for LINDE OXYGEN CONCENTRATOR LOC-II, manufactured by Union Carbide Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K791437 · Union Carbide Corp. · Anesthesiology device
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Sep 1979
Decision
50d
Days
Class 2
Risk

K791437 is an FDA 510(k) clearance for the LINDE OXYGEN CONCENTRATOR LOC-II. 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 Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 50 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K791437

510(k) Number K791437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1979
Decision Date September 19, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 140d · This submission: 50d
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 88
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K791437.
MODEL BX-3000 OXYGEN CONCENTRATOR
K822871 · Healthdyne, Inc. · Oct 1982
MODEL #6200 OXYGEN CONCENTRATOR
K822889 · Hudson Oxygen Therapy Sales Co. · Oct 1982
MODEL 6200 OXYGEN CONCENTRATOR
K813320 · Hudson Oxygen Therapy Sales Co. · Dec 1981
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · Union Carbide Corp. · Jun 1979
AIR ENRICHER
K761213 · Union Carbide Corp. · Dec 1976