Cleared Traditional

K903104 - CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR

K903104 is the FDA 510(k) clearance for CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code CBQ) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K903104 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Jan 1991
Decision
194d
Days
Class 2
Risk

K903104 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on January 23, 1991 after a review of 194 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K903104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1990
Decision Date January 23, 1991
Days to Decision 194 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 140d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K903104.
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K861397 · Ohmeda Medical · May 1986