CCK · Class II · 21 CFR 868.1400

FDA Product Code CCK: Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Under FDA product code CCK, gaseous-phase carbon dioxide analyzers are cleared for continuous capnography during anesthesia and critical care.

These devices measure end-tidal CO2 concentration in exhaled gas to confirm endotracheal tube placement, monitor ventilation adequacy, and detect respiratory compromise. Capnography is now a standard of care during general anesthesia and procedural sedation.

CCK devices are Class II medical devices, regulated under 21 CFR 868.1400 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Oridion Medical 1987 , Ltd., Datex Division Instrumentarium Corp. and Nihon Kohden America, Inc..

307
Total
307
Cleared
148d
Avg days
1977
Since
307 devices
73–96 of 307
Cleared Dec 10, 2009
ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
K093525
Ventlab Corp.
Anesthesiology · 24d
Cleared Mar 02, 2009
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Mar 26, 2008
VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
K063813
Ventlab Corp.
Anesthesiology · 460d
Cleared Nov 29, 2007
YG-125T AND YG-135T NASAL ADAPTER
K072843
Nihon Kohden America, Inc.
Anesthesiology · 56d
Cleared Dec 27, 2006
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
K062115
Nihon Kohden America, Inc.
Anesthesiology · 156d
Cleared Nov 02, 2005
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
K052880
Ge Healthcare
Anesthesiology · 21d
Cleared Oct 14, 2005
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
K052582
Ge Healthcare
Anesthesiology · 24d
Cleared Sep 08, 2005
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
K052167
Ge Healthcare
Anesthesiology · 30d
Cleared Mar 01, 2005
C-CO2 COLORIMETRIC CO2 INDICATOR
K050066
Marquest Medical Products, Inc.
Anesthesiology · 48d
Cleared Nov 23, 2004
SMART BITEBLOC
K042665
Oridion Medical 1987 , Ltd.
Anesthesiology · 55d
Cleared Nov 19, 2004
CAPNOSTAT 5
K042601
Respironics Novametrix, Inc.
Anesthesiology · 56d
Cleared Oct 15, 2004
CAP-ONE, MODEL TG-920P
K040875
Nihon Kohden America, Inc.
Anesthesiology · 196d
Cleared Aug 09, 2004
EMG - ESSENTIAL GAS MODULE, MODEL M1013A
K041956
Draeget Medical AG & Co. Kgaa
Anesthesiology · 19d
Cleared Jun 18, 2004
MODIFICATION TO NICO WITH MARS, MODEL 7300
K041450
Respironics Novametrix, Inc.
Anesthesiology · 17d
Cleared Jun 17, 2004
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
K040847
Draeger Medical, Inc.
Anesthesiology · 77d
Cleared Feb 09, 2004
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741
Alaris Medical Systems, Inc.
Anesthesiology · 250d
Cleared Apr 23, 2003
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454
Datex-Ohmeda
Anesthesiology · 190d
Cleared Jan 28, 2003
GAS SAMPLING LINES
K023579
Promedic, Inc.
Anesthesiology · 96d
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046
Nihon Kohden America, Inc.
Anesthesiology · 199d
Cleared Jan 17, 2002
VAMOS ANESTHETIC GAS MONITOR
K012139
Draeger Medical, Inc.
Anesthesiology · 191d
Cleared Nov 29, 2001
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
K013845
Oridion Medical 1987 , Ltd.
Anesthesiology · 9d
Cleared Nov 14, 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
K011536
Oridion Medical 1987 , Ltd.
Anesthesiology · 180d
Cleared Aug 15, 2001
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
K012391
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
K012394
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d