Cleared Traditional

K910106 - DATASCOPE MULTINEX ID MONITOR

K910106 is the FDA 510(k) clearance for DATASCOPE MULTINEX ID MONITOR by Datascope Corp.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K910106 · Datascope Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
78d
Days
Class 2
Risk

K910106 is an FDA 510(k) clearance for the DATASCOPE MULTINEX ID MONITOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datascope Corp. devices

Submission Details

510(k) Number K910106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date March 29, 1991
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 119
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K910106.
GAS SAMPLING INTERFACES
K914337 · Vital Signs, Inc. · Mar 1992
OHMEDA MODEL 4700 OXICAP
K911193 · Ohmeda Medical · Aug 1991
SERIES 7000 CARBON DIOXIDE MODULE
K904789 · Marquette Electronics, Inc. · May 1991
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
K910019 · Novametrix Medical Systems, Inc. · Mar 1991
CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR
K896652 · Datex Division Instrumentarium Corp. · Sep 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · S & W Medico Teknik · Feb 1990