Cleared Traditional

K874663 - MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874663 · Ametek/Thermox Instruments Division · Anesthesiology device
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May 1988
Decision
200d
Days
Class 2
Risk

K874663 is an FDA 510(k) clearance for the MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Ametek/Thermox Instruments Division (Pittsburgh, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 200 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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 Ametek/Thermox Instruments Division devices

Submission Details

510(k) Number K874663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date May 31, 1988
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 139d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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.