Cleared Traditional

K932098 - CAPNOMAC ULTIMA ANESTHESIA MONITOR

K932098 is the FDA 510(k) clearance for CAPNOMAC ULTIMA ANESTHESIA MONITOR by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K932098 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Nov 1993
Decision
210d
Days
Class 2
Risk

K932098 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA ANESTHESIA MONITOR. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on November 29, 1993 after a review of 210 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 K932098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date November 29, 1993
Days to Decision 210 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
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 10
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