Cleared Traditional

K821393 - SYSTEM ONE OXYGEN CONCENTRATOR

K821393 is the FDA 510(k) clearance for SYSTEM ONE OXYGEN CONCENTRATOR by Marathon. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K821393 · Marathon · Anesthesiology device

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Aug 1982

Decision

91d

Days

Class 2

Risk

K821393 is an FDA 510(k) clearance for the SYSTEM ONE OXYGEN 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 Marathon (Mchenry, US). The FDA issued a Cleared decision on August 10, 1982 after a review of 91 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 Marathon devices

Submission Details

510(k) Number	K821393 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 11, 1982
Decision Date	August 10, 1982
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

49d faster than avg

Panel avg: 140d · This submission: 91d

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 K821393.

MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR

K851439 · Invacare Corp. · Jul 1985

COMPANION 492 OXYGEN CONCENTRATOR

K843243 · Puritan Bennett Corp. · Aug 1984

OXYGEN CONCENTRATOR

K823524 · C.R. Bard, Inc. · Dec 1982

LINDE OXYGEN CONCENTRATOR LOC-II

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K821393

Marathon

Mchenry, IL · US

Regulatory profile

3 submissions 3 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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