Cleared Traditional

K813058 - PORTABLE OXYGEN GENERATOR

K813058 is the FDA 510(k) clearance for PORTABLE OXYGEN GENERATOR by Respiratory Marketing, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K813058 · Respiratory Marketing, Inc. · Anesthesiology device
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Dec 1981
Decision
34d
Days
Class 2
Risk

K813058 is an FDA 510(k) clearance for the PORTABLE OXYGEN GENERATOR. 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 Respiratory Marketing, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 34 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 Respiratory Marketing, Inc. devices

Submission Details

510(k) Number K813058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1981
Decision Date December 03, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K813058.
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
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OXYGEN CONCENTRATOR
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K791437 · Union Carbide Corp. · Sep 1979
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
K791043 · Union Carbide Corp. · Jun 1979
AIR ENRICHER
K761213 · Union Carbide Corp. · Dec 1976