Cleared Traditional

K904863 - MGA-IR SIDESTREAM PCO2 MODULE

K904863 is an FDA 510(k) clearance for MGA-IR SIDESTREAM PCO2 MODULE, manufactured by Marquette Gas Analysis Corp.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K904863

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.

CCK Device Classification - Class 2, Special Controls

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

All 274
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K904863 · MGA-IR SIDESTREAM PCO2 MODULE
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