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
97–120 of 307
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 May 13, 2004
POLARIS 2004 CAPNOGRAPH
K040011
Oridion , Ltd.
Anesthesiology · 129d
Cleared Feb 09, 2004
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741
Alaris Medical Systems, Inc.
Anesthesiology · 250d
Cleared Oct 07, 2003
NICO WITH MARS, MODEL 7300
K030886
Respironics Novametrix, Inc.
Anesthesiology · 200d
Cleared Aug 19, 2003
ADVISOR, MODEL 9200
K030407
Bci, Inc.
Anesthesiology · 193d
Cleared Aug 14, 2003
STATCO2METER, MODEL 10-55372
K031814
Mercury Medical
Anesthesiology · 63d
Cleared Jul 30, 2003
MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
K031411
Mercury Medical
Anesthesiology · 86d
Cleared May 07, 2003
CO2 CLIP
K023820
Bregas AB
Anesthesiology · 173d
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 Nov 04, 2002
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
K021576
Mercury Medical
Anesthesiology · 174d
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046
Nihon Kohden America, Inc.
Anesthesiology · 199d
Cleared Jun 11, 2002
OXYARM CO2
K014211
Southmedic, Inc.
Anesthesiology · 172d
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
Cleared Aug 15, 2001
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
K012395
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared May 04, 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
K011050
Oridion Medical 1987 , Ltd.
Anesthesiology · 28d
Cleared Apr 11, 2001
CAPNOPROBE SL, MODEL 2000
K010795
Optical Sensors, Inc.
Anesthesiology · 26d