Cleared Traditional

K891076 - CAPNOMAC II(TM) ANESTHESIA MULTIGAS MON...

K891076 is the FDA 510(k) clearance for CAPNOMAC II(TM) ANESTHESIA MULTIGAS MON... by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K891076 · Datex Division Instrumentarium Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
155d
Days
Class 2
Risk

K891076 is an FDA 510(k) clearance for the CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Melrose, US). The FDA issued a Cleared decision on August 2, 1989 after a review of 155 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

Submission Details

510(k) Number K891076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date August 02, 1989
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
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 80
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K891076.
DATASCOPE MULTINEX ID MONITOR
K910106 · Datascope Corp. · Mar 1991
MODEL AO-800PA CO2 MODULE
K894691 · Nihon Kohden America, Inc. · Dec 1989
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K896030 · Hewlett-Packard Co. · Dec 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · Gambro, Inc. · Mar 1989
VITALERT 1000 MONITORING SYSTEM
K873380 · Draeger Medical, Inc. · Apr 1988
SERIES 7050 CAPNOGRAPH
K860556 · Marquette Electronics, Inc. · Feb 1986