Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
FDA product code CCK · Class II (moderate risk) · 21 CFR 868.1400 · Anesthesiology
307510(k) clearances
0PMA approvals
80recalls
Manufacturers
- Oridion Medical 1987 Ltd. 17
- Nihon Kohden America, Inc. 9
- Datex Division Instrumentarium Corp. 9
- Salter Labs 8
- Biochem International, Inc. 6
- Ohmeda Medical 6
- Nihon Kohden Corporation 6
- Draeger Medical, Inc. 6
- Hewlett-Packard Co. 6
- Fenem, Inc. 5
- Ppg/Applied Resources, Inc. 5
- Marquette Electronics, Inc. 5
- Tri-Med, Inc. 5
- Phasein AB 5
- Novametrix Medical Systems, Inc. 5
- Spegas Industries, Ltd. 5
- Oridion Medical , Ltd. 4
- Respironics Novametrix, Inc. 4
- GE Healthcare Finland Oy 4
- Mercury Medical 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
| K213767 | Endure ETCO2/02 Nasal CannulaCCK · Traditional | Endure Industries, Inc. | 09/12/2023SE |
| K221118 | CO2 Mainstream SensorCCK · Traditional | Draegerwerk AG & CO Kgaa | 04/05/2023SE |
| K210112 | XChange Device, XChange SystemCCK · Traditional | Pneuma Therapeutics, Inc. | 01/30/2023SE |
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | Engineered Medical Systems, Inc. | 11/16/2022SE |
| K213911 | Microstream CO2 NanoPodCCK · Traditional | Covidien, LLC | 07/29/2022SE |
| K213518 | CARESCAPE CO2 Microstream parameterCCK · Traditional | Covidien, LLC | 04/12/2022SE |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…CCK · Traditional | GE Healthcare Finland Oy | 10/21/2021SE |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric…CCK · Traditional | Covidien | 09/17/2021SE |
| K201590 | EMMA CapnographCCK · Special | Masimo Corporation | 03/29/2021SE |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+CCK · Traditional | Unimed Medical Supplies, Inc. | 03/04/2021SE |
| K192488 | CO2 Sidestream ModuleCCK · Traditional | Beijing Kingst Commercial & Trade Co., Ltd. | 05/22/2020SE |
| K192446 | CO2 Mainstream ModuleCCK · Traditional | Beijing Kingst Commercial & Trade Co., Ltd. | 05/21/2020SE |
| K200594 | Capnostream 35 Portable Respiratory MonitorCCK · Traditional | Oridion Medical 1987 , Ltd. | 04/27/2020SE |
| K192563 | Altera gas Sampling LinesCCK · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 01/17/2020SE |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling…CCK · Traditional | Bluepoint Medical GmbH & Co. KG | 12/18/2019SE |
| K182362 | MaxCap Ped and MaxCap NeoCCK · Traditional | Maxtec, LLC | 05/23/2019SE |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOCCK · Special | GE Healthcare Finland Oy | 05/01/2019SE |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream…CCK · Traditional | Oridion Medical 1987 , Ltd. | 03/22/2019SE |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance…CCK · Traditional | Oridion Medical 1987 , Ltd. | 02/08/2019SE |
| K181981 | CO2 Sampling LineCCK · Traditional | Tylenol Medical Instruments Co., Ltd. | 02/06/2019SE |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyCCK · Traditional | Medipines Corporation | 01/11/2019SE |
| K170820 | Capnograph and OximeterCCK · Traditional | Cmi Health, Inc. | 07/18/2018SE |
| K173147 | SuperNO2VA Et DeviceCCK · Traditional | Revolutionary Medical Devices, Inc. | 06/20/2018SE |
| K171828 | ETCO2 SensorCCK · Traditional | Orantech, Inc. | 05/31/2018SE |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas…CCK · Traditional | Vyaire Medical, Inc. | 04/30/2018SE |
| K172365 | Panoramic Oxygen Mask (POM)CCK · Traditional | Pom Medical, LLC | 04/19/2018SE |
| K171235 | OmniCapCCK · Traditional | Respirion, Inc. | 01/04/2018SE |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream ExtensionCCK · Traditional | Philips Medizin Systeme Boeblingen GmbH | 12/26/2017SE |
| K171765 | Nihon Kohden CO2 MonitorCCK · Traditional | Nihon Kohden Corporation | 10/11/2017SE |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and…CCK · Traditional | GE Healthcare Finland Oy | 08/17/2017SE |
| K161250 | OC-FLEX Flexible IntraOral CannulaCCK · Traditional | Venture Therapeutics, Inc. | 03/17/2017SE |
| K161860 | TG-970P CO2 Sensor KitCCK · Traditional | Nihon Kohden Corporation | 02/24/2017SE |
| K162343 | Westmed Gas Sampling Cannula with O2 deliveryCCK · Traditional | Westmed, Inc. | 12/14/2016SE |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…CCK · Traditional | Salter Labs | 03/10/2016SE |
| K150272 | Capnostream 35 Portable Respiratory MonitorCCK · Traditional | Oridion Medical 1987 , Ltd. | 07/17/2015SE |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXCCK · Traditional | GE Healthcare Finland Oy | 07/17/2015SE |
| K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleCCK · Traditional | Dispo-Med (Malaysia) Sdn Bhd | 02/13/2015SE |
| K143469 | SOFTECH Plus ETCO2 CannulaCCK · Special | Teleflexmedical, Inc. | 02/12/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | Besmed Health Business Corp | 02/05/2015SE |
| K142467 | IntelAir Nasal Airway Support SystemCCK · Special | Abeon Medical Corporation | 11/24/2014SE |
| K123690 | CAPNOSTREAM20P with Hifi C02 MonitoringCCK · Traditional | Oridion Medical 1987 , Ltd. | 08/05/2014SE |
| K132946 | Softech Plus ETC02 CannulaCCK · Traditional | Teleflexmedical, Inc. | 06/04/2014SE |
| K133516 | CO2 Monitoring Line, CO2 Monitoring Line with FilterCCK · Traditional | Flexicare | 04/30/2014SE |
| K140473 | DualguardCCK · Traditional | Flexicare Medical, Ltd. | 04/10/2014SE |
| K133540 | FlocapCCK · Traditional | Maxtec, Inc. | 03/28/2014SE |
| K140113 | O2 Nasal Cannula with CO2 MonitoringCCK · Traditional | Flexicare Medical, Ltd. | 03/06/2014SE |
| K131506 | Airway Support System / AirportCCK · Traditional | Abeon Medical Corporation | 03/06/2014SE |
| K131410 | CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8…CCK · Traditional | Southmedic, Inc. | 01/13/2014SE |
| K133806 | M1 Capnography MaskCCK · Traditional | Monitor Mask, Inc. | 12/31/2013SE |
| K131339 | CapnomaskCCK · Traditional | Mediplus , Ltd. | 11/25/2013SE |
| K122214 | TG-970P Sensor Kit W/ New Airway Adapter (YG-213T)CCK · Traditional | Nihon Kohden Corp. | 05/21/2013SE |
| K130112 | Capno Module, 92517CCK · Special | Spacelabs Healthcare | 03/21/2013SE |
| K122075 | Disposable Gas Sampling Line with and Without In-Line FilterCCK · Traditional | Intersurgical, Inc. | 12/20/2012SE |
| K121927 | Microstream Filterline ICUCCK · Traditional | Oridion Medical 1987 , Ltd. | 11/29/2012SE |
| K123043 | Irma C02 Model 200101; Irma Ax 200601CCK · Special | Phasein AB | 10/25/2012SE |
| K112368 | CAPNOSTREAM20P with Ai/OdiCCK · Traditional | Oridion Medical 1987 , Ltd. | 07/19/2012SE |
| K121017 | Capnography Pad (92516)CCK · Special | Spacelabs Healthcare | 07/13/2012SE |
| K112840 | Capnodura Combi & Capnodura Pedi CO2 DetectorCCK · Traditional | Seebreath AB | 07/13/2012SE |
| K120518 | End Tidal CO2 Nasal CannulaCCK · Traditional | Care Fusion | 05/04/2012SE |
| K110594 | GF-210R Multi-Gas Module for Nohon Kohden Bedside MonitorsCCK · Traditional | Nihon Kohden Corp. | 10/28/2011SE |
| K103604 | Isa CO2, Isa Ax+, Isa Or+CCK · Traditional | Phasein AB | 04/06/2011SE |
| K094012 | CAPNOSTREAM20 with MICROMEDICO2 ModuleCCK · Special | Oridion Capnography, Inc. | 05/12/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | Draeger Medical AG & Co. KG | 04/23/2010SE |
| K093388 | Smart Capnoline GuardianCCK · Traditional | Oridion Medical 1987 , Ltd. | 03/04/2010SE |
| K093525 | Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult…CCK · Special | Ventlab Corp. | 12/10/2009SE |
| K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special | Nihon Kohden America, Inc. | 03/02/2009SE |
| K083056 | Neo-Stat CO2 <KgCCK · Traditional | Mercury Medical | 02/23/2009SE |
| K080527 | Twinguard with Capnograph AccessoryCCK · Traditional | Trawax Pty Limited | 10/31/2008SE |
| K081601 | Veo Multigas Monitor for Pocket PCCCK · Traditional | Phasein AB | 09/04/2008SE |
| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | Ventlab Corp. | 03/26/2008SE |
| K072813 | Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)CCK · Traditional | Phasein AB | 12/28/2007SE |
| K072843 | YG-125T and YG-135T Nasal AdapterCCK · Special | Nihon Kohden America, Inc. | 11/29/2007SE |
| K072220 | Pedi CO2 EasyCCK · Traditional | Westmed, Inc. | 08/23/2007SE |
| K070128 | CO2 EasyCCK · Traditional | Westmed, Inc. | 02/15/2007SE |
| K063167 | Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)CCK · Traditional | Phasein AB | 02/06/2007SE |
| K062115 | Carbon Dioxide Monitor, Model OLG-2800ACCK · Special | Nihon Kohden America, Inc. | 12/27/2006SE |
| K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013ACCK · Special | Draeger Medical AG & Co. Kgaa | 02/03/2006SE |
| K053174 | Loflo C5 CO2 SensorCCK · Special | Respironics Novametrix, LLC | 01/12/2006SE |
| K053063 | Pro-Flow Multipurpose CannulaCCK · Traditional | Pro-Tech Services, Inc. | 12/13/2005SE |
| K052880 | Datex-Ohmeda S/5 Interface Module E-IntCCK · Special | GE Healthcare | 11/02/2005SE |
| K052582 | Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and AccessoriesCCK · Special | GE Healthcare | 10/14/2005SE |
| K051857 | Veo Multigas Monitor for Pocket PC, Model 400221CCK · Traditional | Weissburg Associates | 09/15/2005SE |
| K052167 | Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesCCK · Special | GE Healthcare | 09/08/2005SE |
| K050066 | C-CO2 Colorimetric CO2 IndicatorCCK · Traditional | Marquest Medical Products, Inc. | 03/01/2005SE |
| K042665 | Smart BiteblocCCK · Traditional | Oridion Medical 1987 , Ltd. | 11/23/2004SE |
| K042601 | Capnostat 5CCK · Special | Respironics Novametrix, Inc. | 11/19/2004SE |
| K040875 | Cap-One, Model TG-920PCCK · Traditional | Nihon Kohden America, Inc. | 10/15/2004SE |
| K041956 | Emg - Essential Gas Module, Model M1013ACCK · Special | Draeget Medical AG & Co. Kgaa | 08/09/2004SE |
| K041450 | Modification to Nico with Mars, Model 7300CCK · Special | Respironics Novametrix, Inc. | 06/18/2004SE |
| K040847 | Modification to Vamos Anesthetic Gas MonitorCCK · Special | Draeger Medical, Inc. | 06/17/2004SE |
| K040011 | Polaris 2004 CapnographCCK · Special | Oridion , Ltd. | 05/13/2004SE |
| K031741 | Medley ETCO2 Module (Includes Accessories), Model 8300CCK · Traditional | Alaris Medical Systems, Inc. | 02/09/2004SE |
| K030886 | Nico with Mars, Model 7300CCK · Traditional | Respironics Novametrix, Inc. | 10/07/2003SE |
| K030407 | Advisor, Model 9200CCK · Traditional | Bci, Inc. | 08/19/2003SE |
| K031814 | STATCO2METER, Model 10-55372CCK · Traditional | Mercury Medical | 08/14/2003SE |
| K031411 | Mini STATCO2 CO2 Detector, Model 10-55371CCK · Traditional | Mercury Medical | 07/30/2003SE |
| K023820 | CO2 ClipCCK · Traditional | Bregas AB | 05/07/2003SE |
| K023454 | Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesCCK · Abbreviated | Datex-Ohmeda | 04/23/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | Promedic, Inc. | 01/28/2003SE |
| K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370CCK · Traditional | Mercury Medical | 11/04/2002SE |
| K020046 | Multigas Unit, Model AG-920RACCK · Traditional | Nihon Kohden America, Inc. | 07/25/2002SE |
| K014211 | Oxyarm CO2CCK · Traditional | Southmedic, Inc. | 06/11/2002SE |
| K012139 | Vamos Anesthetic Gas MonitorCCK · Abbreviated | Draeger Medical, Inc. | 01/17/2002SE |
| K013845 | Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample LineCCK · Special | Oridion Medical 1987 , Ltd. | 11/29/2001SE |
| K011536 | Microstream O2/CO2 Oral Nasal FilterlineCCK · Special | Oridion Medical 1987 , Ltd. | 11/14/2001SE |
| K012395 | Mac-Line 02/CO2 Nasal Cannula Sample LineCCK · Special | Oridion Medical 1987 , Ltd. | 08/15/2001SE |
| K012394 | Oridion Mac-Line Oral Nasal Cannula Sample LineCCK · Special | Oridion Medical 1987 , Ltd. | 08/15/2001SE |
| K012391 | Mac-Line CO2 Nasal Cannula Sample LineCCK · Special | Oridion Medical 1987 , Ltd. | 08/15/2001SE |
| K011050 | Microstream Oral Nasal Cannula FilterlineCCK · Special | Oridion Medical 1987 , Ltd. | 05/04/2001SE |
| K010795 | Capnoprobe SL, Model 2000CCK · Special | Optical Sensors, Inc. | 04/11/2001SE |
| K010024 | O2/CO2 Nasal FilterlineCCK · Traditional | Oridion Medical 1987 , Ltd. | 03/14/2001SE |
| K003550 | Infinity ETCO2 + Respiratory Mechanics PodCCK · Traditional | Siemens Medical Solutions USA, Inc. | 03/07/2001SE |
| K003982 | Temperature Function, Model 9500 Multigas MonitorCCK · Traditional | Magnetic Resonance Equipment Corp. | 01/26/2001SE |
| K002163 | Microstream External Battery ChargerCCK · Traditional | Oridion Medical 1987 , Ltd. | 01/11/2001SE |
| K984579 | Capno Probe aCCK · Traditional | Optical Sensors, Inc. | 12/21/2000SE |
| K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and AccessoriesCCK · Abbreviated | Datex-Ohmeda | 08/23/2000SE |
| K000520 | C-ItCCK · Traditional | Bregas AB | 05/16/2000SE |
| K000712 | Portable Intensive Care Unit, Model PicCCK · Special | Medical Research Laboratories, Inc. | 04/27/2000SE |
| K993656 | Datex-Ohmeda Tonometry Module M-TonoCCK · Traditional | Datex-Ohmeda, Inc. | 03/15/2000SE |
| K992116 | Siememns Infinity ETC02 PodCCK · Traditional | Siemens Medical Solutions USA, Inc. | 01/12/2000SE |
| K983864 | ETCO2 Vital Signs ModuleCCK · Traditional | Mennen Medical, Inc. | 10/08/1999SE |
| K982969 | Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847CCK · Traditional | Nonin Medical, Inc. | 08/12/1999SE |
| K991086 | Capnocheck II, Model 8400CCK · Traditional | Bci Intl., Inc. | 06/09/1999SE |
| K990063 | Nihon Kohden TG-901T CO2 Sensor Kit with AccessoriesCCK · Traditional | Nihon Kohden America, Inc. | 06/09/1999SE |
| K983114 | MAGNATEK80CCK · Traditional | Magna Advanced Technologies, Inc. | 09/22/1998SE |
| K982846 | MTEK-1400CCK · Traditional | Magna Advanced Technologies, Inc. | 09/18/1998SE |
| K981114 | MicrocapCCK · Traditional | Oridion Medical , Ltd. | 06/25/1998SE |
| K980979 | Fukuda Denshi Model HC-500 End Tidal CO2 ModuleCCK · Traditional | Fukuda Denshi USA, Inc. | 06/12/1998SE |
| K973544 | Vacu*Med, Gold Edition Carbon Dioxide Gas AnalyzerCCK · Traditional | Vacumed, Div. of Vacumetrics, Inc. | 05/26/1998SE |
| K980384 | Trip Tonometry Catheter, 18FCCK · Traditional | Datex-Engstrom, Inc. | 05/01/1998SE |
| K980327 | Microstream Filterline ICUCCK · Traditional | Oridion Medical , Ltd. | 04/16/1998SE |
| K980325 | Microstream Nasal Cannula FilterlineCCK · Traditional | Oridion Medical , Ltd. | 04/16/1998SE |
| K980324 | Microstream Fillerline Or/EmsCCK · Traditional | Oridion Medical , Ltd. | 04/16/1998SE |
| K973984 | Rac 2A Module HousingCCK · Traditional | Marquette Medical Systems, Inc. | 01/16/1998SE |
| K971229 | Capnoxygen MaskCCK · Traditional | Medsys, Inc. | 09/23/1997SE |
| K964961 | Model 405T with ETCO2 OptionCCK · Traditional | Ivy Biomedical Systems, Inc. | 05/14/1997SE |
| K964239 | Combination Oximeter/Carbon Dioxide Gas AnalyzerCCK · Traditional | Spegas Industries, Ltd. | 05/09/1997SE |
| K970209 | Capnocheck PlusCCK · Traditional | Bci Intl., Inc. | 04/18/1997SE |
| K962638 | Tonocap, TC-200 and Accessory CathetersCCK · Traditional | Instrumentarium Corp. | 04/04/1997SE |
| K954120 | Model 9500 Mr-Compatible Multigas MonitorCCK · Traditional | Magnetic Resonance Equipment Corp. | 04/02/1997SE |
| K964305 | Nihon Kohden OLG-100A Pocketcap Pocket CO2 Monitor with AccessoriesCCK · Traditional | Nihon Kohden America, Inc. | 02/19/1997SE |
| K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610CCK · Traditional | Novametrix Medical Systems, Inc. | 11/20/1996SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | Marquest Medical Products, Inc. | 10/18/1996SE |
| K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaCCK · Traditional | Hudson Respiratory Care, Inc. | 09/10/1996SE |
| K954402 | Et-Tube Placement Detector (with Colibri Indicator)CCK · Traditional | Icor AB | 05/22/1996SE |
| K954632 | Siemens SC 9000 ETCO2 ModuleCCK · Traditional | Siemens Medical Solutions USA, Inc. | 02/05/1996SE |
| K953006 | AS/3 Network LinkCCK · Traditional | Datex Medical Instrumentation, Inc. | 09/27/1995SE |
| K950044 | Fukuda Denshi Model HC-300 End Tidal CO2 ModuleCCK · Traditional | Fukuda Denshi USA, Inc. | 09/15/1995SE |
| K952325 | Et Tube Placement Detector (with Colibri Indicator)CCK · Traditional | Icor AB | 07/31/1995SE |
| K944052 | Rascal-Ii Respiratory and Anesthetic Gas MonitorCCK · Traditional | Ohmeda Medical | 07/07/1995SE |
| K950387 | GeminiCCK · Traditional | Spegas Industries, Ltd. | 05/03/1995SE |
| K950388 | PolarisCCK · Traditional | Spegas Industries, Ltd. | 05/02/1995SE |
| K950581 | Smart Anesthesia Multi-Gas (Sam) ModuleCCK · Traditional | Marquette Electronics, Inc. | 03/29/1995SE |
| K951127 | Hewlett-Packard Model M1026A Anesthetic Gas ModuleCCK · Traditional | Hewlett-Packard GmbH | 03/24/1995SE |
| K943977 | Smart Anesthesia Multi-Gas (Sam) ModuleCCK · Traditional | Marquette Electronics, Inc. | 03/23/1995SE |
| K943389 | Sidestream Pump Plug-In Module of Component Monitoring SystemCCK · Traditional | Hewlett-Packard Co. | 03/17/1995SE |
| K944541 | Handypack 911SCCCK · Traditional | Pace Tech, Inc. | 02/22/1995SE |
| K942849 | CapnosatCCK · Traditional | Spegas Industries, Ltd. | 02/21/1995SE |
| K942113 | Carbon Dioxide Analyzer (Model CD-3A)CCK · Traditional | Ametek, Inc. | 02/16/1995SE |
| K946044 | Disposable Gas Sampling LinesCCK · Traditional | Catheter Research, Inc. | 12/27/1994SE |
| K941971 | 9100 Mutigas MonitorCCK · Traditional | Bci Intl., Inc. | 11/21/1994SE |
| K941982 | CapnocheckCCK · Traditional | Bci, Inc. | 10/17/1994SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | Spacelabs, Inc. | 10/06/1994SE |
| K944400 | Pedi-CapCCK · Traditional | Nellcor, Inc. | 09/27/1994SE |
| K925701 | Minipack 911-STCCCK · Traditional | Pace Tech, Inc. | 08/11/1994SE |
| K935477 | AS/3(TM) Anesthesia Monitor Syst Interface BoardCCK · Traditional | Datex Division Instrumentarium Corp. | 08/01/1994SE |
| K942772 | A-200 Multi-Use Airway AdapterCCK · Traditional | Pryon Corp. | 07/25/1994SE |
| K935272 | Cap 400 atCCK · Traditional | Pryon Corp. | 07/13/1994SE |
| K933284 | AS/3 TM NetworkCCK · Traditional | Datex Division Instrumentarium Corp. | 07/11/1994SE |
| K942567 | Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K930524 | End Tidal CO2 Option BCCK · Traditional | Medical Data Electronics | 02/07/1994SE |
| K933707 | CapnodigCCK · Traditional | Spegas Industries, Ltd. | 10/27/1993SE |
| K930250 | Low Dead Space Adaptor & Reuasable Airway AdaptorCCK · Traditional | Pryon Corp. | 10/15/1993SE |
| K933980 | HP M1465A Standard Airway AdapterCCK · Traditional | Hewlett-Packard Co. | 09/09/1993SE |
| K930559 | Vitalmax 800-CCCK · Traditional | Pace Tech, Inc. | 09/03/1993SE |
| K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60CCK · Traditional | Nellcor, Inc. | 08/06/1993SE |
| K930957 | Zefon Gas Sampling LinesCCK · Traditional | Zefon Medical Products | 07/02/1993SESK |
| K925484 | Carbon Dioxide & Oxygen Monitor Type 1308CCK · Traditional | Bruel & Kjaer | 06/22/1993SE |
| K930866 | Rascal IICCK · Traditional | Ohmeda Medical | 05/13/1993SE |
| K925424 | Medical Manufacturing Inc Gas Sampling Lines&Conn.CCK · Traditional | Medical Manufacturers, Inc. | 04/19/1993SESK |
| K921497 | Propaq Monitors, ModificationCCK · Traditional | Protocol Systems, Inc. | 03/23/1993SE |
| K920915 | Capnomed 100 Stand-Alone ETCO2 ModuleCCK · Traditional | Mennen Medical, Inc. | 03/23/1993SE |
| K924083 | 700/700-1CCK · Traditional | Citicare Systems, Inc. | 03/10/1993SE |
| K925167 | Mass Spectrometry Monitoring Line CononectorsCCK · Traditional | Merit Medical Systems, Inc. | 01/22/1993SE |
| K923305 | Battery PacksCCK · Traditional | Access / God Loves You | 12/17/1992SE |
| K913995 | Vitalert 3000 Monitoring SystemCCK · Traditional | Draeger Medical, Inc. | 11/03/1992SE |
| K921526 | Datascope Passport Monitor with CO2CCK · Traditional | Datascope Corp. | 10/14/1992SE |
| K920622 | Rascal IICCK · Traditional | Ohmeda Medical | 10/13/1992SE |
| K920590 | Ohmeda Model 5250 RGM MonitorCCK · Traditional | Ohmeda Medical | 08/31/1992SE |
| K911970 | Nasal/Oral 02 Delivery and Gas Sampling DeviceCCK · Traditional | Nasorcap Ent., Inc. | 08/14/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1722-2025 Class II | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub…Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible. | Philips North America Llc | 04/07/2025Open, Classified |
| Z-1385-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1384-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1383-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1382-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1381-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1380-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1379-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1378-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1377-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1376-2025 Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF:…Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated… | Oridion Medical 1987 Ltd. | 02/17/2025Open, Classified |
| Z-1405-2025 Class II | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure… | Smiths Medical ASD, Inc. | 02/14/2025Open, Classified |
| Z-1404-2025 Class II | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure… | Smiths Medical ASD, Inc. | 02/14/2025Open, Classified |
| Z-0314-2025 Class II | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and…Due to products being shipped/distributed to customers after the products expiration date had past. | Nihon Kohden America Inc | 04/29/2022Open, Classified |
| Z-2141-2021 Class II | OxyMask O2 Adult REF OM-1125-14Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of… | Southmedic, Inc. | 05/25/2021Open, Classified |
| Z-0515-2021 Class II | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01…The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of… | Covidien Llc | 11/16/2020Open, Classified |
| Z-0760-2020 Class I | Airway Gas Option N-CAiODisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0759-2020 Class I | CARESCAPE Respiratory Module E-sCAiOVEDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0758-2020 Class I | CARESCAPE Respiratory Module E-sCAiOEDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0757-2020 Class I | CARESCAPE Respiratory Module E-sCAiOVDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0756-2020 Class I | CARESCAPE Respiratory Module E-sCAiODisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0755-2020 Class I | CARESCAPE Respiratory Module E-sCOVXDisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-0754-2020 Class I | CARESCAPE Respiratory Module E-sCODisplayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could… | GE Healthcare, LLC | 09/27/2019Terminated |
| Z-2443-2019 Class II | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and…Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using… | CareFusion 303, Inc. | 07/01/2019Terminated |
| Z-0027-2019 Class II | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0026-2019 Class II | CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0025-2019 Class II | CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0024-2019 Class II | CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0021-2019 Class II | CAPNOSTREAM 20P (US) N, Part Number CS08651-01The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-2379-2018 Class II | BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235…Some printing modes on the devices may not function properly (tabular data printing, real-time continuous… | Smiths Medical ASD Inc. | 11/29/2017Terminated |
| Z-1288-2018 Class II | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per…Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. | Southmedic, Inc. | 10/17/2017Terminated |
| Z-1577-2016 Class I | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery…Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the… | Medtronic | 04/13/2016Terminated |
| Z-1880-2016 Class II | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas…Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple… | Ventlab LLC | 03/15/2016Terminated |
| Z-0455-2016 Class II | Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal…CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service… | CareFusion 303, Inc. | 11/12/2015Terminated |
| Z-1692-2015 Class II | Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data… | Smiths Medical ASD, Inc. | 03/21/2015Terminated |
| Z-2068-2014 Class I | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM…Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous… | GE Healthcare, LLC | 06/11/2014Terminated |
| Z-0360-2014 Class II | Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in…It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock… | Salter Labs | 11/01/2013Terminated |
| Z-1014-2013 Class I | Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder…In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some… | Smiths Medical ASD, Inc. | 02/06/2013Terminated |
| Z-1898-2012 Class II | Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen…A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector… | Salter Labs | 05/30/2012Terminated |
| Z-1334-2012 | Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling…CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may… | Oridion Medical 1987 Ltd. | 02/16/2012Terminated |
| Z-1333-2012 | Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling…CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may… | Oridion Medical 1987 Ltd. | 02/16/2012Terminated |
| Z-1332-2012 | Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling…CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may… | Oridion Medical 1987 Ltd. | 02/16/2012Terminated |
| Z-0605-2012 | ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707…Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained… | Salter Labs | 12/07/2011Terminated |
| Z-1350-2012 | Oridion Surestream CO2 Sampling Lines- Sure VentLine H Set Adult/Pediatric Part Number:…Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | Oridion Medical 1987 Ltd. | 12/01/2011Terminated |
| Z-1349-2012 | Oridion Surestream CO2 Sampling Lines- Sure VentLine Set Adult/Pediatric Part Number:…Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | Oridion Medical 1987 Ltd. | 12/01/2011Terminated |
| Z-1348-2012 | Oridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03 Product Usage:…Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | Oridion Medical 1987 Ltd. | 12/01/2011Terminated |
| Z-1347-2012 | Oridion Surestream CO2 Sampling Lines- Smart SureLine Plus O2 adult Part Number:…Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | Oridion Medical 1987 Ltd. | 12/01/2011Terminated |
| Z-1346-2012 | Oridion Surestream CO2 Sampling Lines- SureLine Adult Part Number: 010976-03 Product…Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet | Oridion Medical 1987 Ltd. | 12/01/2011Terminated |
| Z-2242-2011 | Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single…One complaint received of product in box different from what was on label. | Salter Laboratories, Division of Regulatory… | 04/19/2011Terminated |
| Z-2237-2011 | Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube…Complaint received that the product in the box was different from labeled product. | Salter Laboratories, Division of Regulatory… | 04/19/2011Terminated |