Cleared Traditional

K834274 - CRITERION I

K834274 is an FDA 510(k) clearance for CRITERION I, manufactured by Timeter Instrument Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K834274

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
Combination Product No
PCCP Authorized No
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.

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 138
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K834274.
ECONO MATE
K843715 · Mountain Medical Equipment, Inc. · Oct 1984
BUNN 3001 OXYGEN CONCENTRATOR
K843811 · The John Bunn Co. · Oct 1984
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · Puritan Bennett Corp. · Aug 1984
BUNN 1000 OXYGEN CONCENTRATOR
K841102 · The John Bunn Co. · Apr 1984
CATALOG 6400 OXYGEN CONCENTRATOR
K833938 · Hudson Oxygen Therapy Sales Co. · Dec 1983
MAX 02 OXYGEN CONCENTRATOR
K833500 · Mountain Medical Equipment, Inc. · Nov 1983