Cleared Traditional

K834274 - CRITERION I

K834274 is the FDA 510(k) clearance for CRITERION I by Timeter Instrument Corp.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K834274 · Timeter Instrument Corp. · Anesthesiology device
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Apr 1984
Decision
127d
Days
Class 2
Risk

K834274 is an FDA 510(k) clearance for the CRITERION I. 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 Timeter Instrument Corp. (Walker, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 127 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 Timeter Instrument Corp. devices

Submission Details

510(k) Number K834274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date April 13, 1984
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 140d · This submission: 127d
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 K834274.
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · Invacare Corp. · Jul 1985
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