Cleared Traditional

K896652 - CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR

K896652 is an FDA 510(k) clearance for CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K896652 · Datex Division Instrumentarium Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
285d
Days
Class 2
Risk

K896652 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on September 5, 1990 after a review of 285 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K896652

510(k) Number K896652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date September 05, 1990
Days to Decision 285 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 140d · This submission: 285d
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 192
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K896652.
PATIENT GAS SAMPLING LINE FOR OHMEDA 6000
K910509 · Intertech Resources, Inc. · Apr 1991
DATASCOPE MULTINEX ID MONITOR
K910106 · Datascope Corp. · Mar 1991
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
K910019 · Novametrix Medical Systems, Inc. · Mar 1991
BIOCHEM 9100 MULTIGAS MONITOR
K901861 · Biochem International, Inc. · Jul 1990
SARA SATCAP
K901132 · Ppg Industries, Inc. · May 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · S & W Medico Teknik · Feb 1990