Cleared Traditional

K904863 - MGA-IR SIDESTREAM PCO2 MODULE

K904863 is the FDA 510(k) clearance for MGA-IR SIDESTREAM PCO2 MODULE by Marquette Gas Analysis Corp.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K904863 · Marquette Gas Analysis Corp. · Anesthesiology device
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Jun 1991
Decision
233d
Days
Class 2
Risk

K904863 is an FDA 510(k) clearance for the MGA-IR SIDESTREAM PCO2 MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Marquette Gas Analysis Corp. (St. Louis, US). The FDA issued a Cleared decision on June 19, 1991 after a review of 233 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Marquette Gas Analysis Corp. devices

Submission Details

510(k) Number K904863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date June 19, 1991
Days to Decision 233 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 140d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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