Cleared Traditional

K960972 - DISPOSABLE GAS SAMPLING INTERFACE KITS

K960972 is an FDA 510(k) clearance for DISPOSABLE GAS SAMPLING INTERFACE KITS, manufactured by Marquest Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K960972 · Marquest Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
221d
Days
Class 2
Risk

K960972 is an FDA 510(k) clearance for the DISPOSABLE GAS SAMPLING INTERFACE KITS. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 221 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 Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K960972

510(k) Number K960972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date October 18, 1996
Days to Decision 221 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 140d · This submission: 221d
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 151
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K960972.
MODEL 405T WITH ETCO2 OPTION
K964961 · Ivy Biomedical Systems, Inc. · May 1997
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · Nihon Kohden America, Inc. · Feb 1997
TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
K963327 · Novametrix Medical Systems, Inc. · Nov 1996
SIEMENS SC 9000 ETCO2 MODULE
K954632 · Siemens Medical Solutions USA, Inc. · Feb 1996
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
K950044 · Fukuda Denshi USA, Inc. · Sep 1995
RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
K944052 · Ohmeda Medical · Jul 1995