Cleared Traditional

K843243 - COMPANION 492 OXYGEN CONCENTRATOR

K843243 is an FDA 510(k) clearance for COMPANION 492 OXYGEN CONCENTRATOR, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K843243 · Puritan Bennett Corp. · Anesthesiology device
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Aug 1984
Decision
368d
Days
Class 2
Risk

K843243 is an FDA 510(k) clearance for the COMPANION 492 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 Puritan Bennett Corp. (Walker, US). The FDA issued a Cleared decision on August 22, 1984 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K843243

510(k) Number K843243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1983
Decision Date August 22, 1984
Days to Decision 368 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
228d slower than avg
Panel avg: 140d · This submission: 368d
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 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K843243.
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · Invacare Corp. · Jul 1985
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · Everest & Jennings, Inc. · Dec 1984
OXYGEN CONCENTRATOR
K844328 · Hospitak, Inc. · Dec 1984
CRITERION I
K834274 · Timeter Instrument Corp. · Apr 1984
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · Hudson Oxygen Therapy Sales Co. · Dec 1983
OXYGEN CONCENTRATOR
K823524 · C.R. Bard, Inc. · Dec 1982