Cleared Traditional

9100 MUTIGAS MONITOR (K941971) - FDA 510(k) Clearance

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

K941971 · Bci Intl., Inc. · Anesthesiology device
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Nov 1994
Decision
213d
Days
Class 2
Risk

K941971 is an FDA 510(k) clearance for the 9100 MUTIGAS MONITOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 213 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 Bci Intl., Inc. devices

Submission Details

510(k) Number K941971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date November 21, 1994
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
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

All 68
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K941971.
SIEMENS SC 9000 ETCO2 MODULE
K954632 · Siemens Medical Solutions USA, Inc. · Feb 1996
RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
K944052 · Ohmeda Medical · Jul 1995
SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM
K943389 · Hewlett-Packard Co. · Mar 1995
HP M1465A STANDARD AIRWAY ADAPTER
K933980 · Hewlett-Packard Co. · Sep 1993
RASCAL II
K930866 · Ohmeda Medical · May 1993
MASS SPECTROMETRY MONITORING LINE CONONECTORS
K925167 · Merit Medical Systems, Inc. · Jan 1993