FDA Product Code
FDA Product Code CCK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1400
510(k) Clearances — 307 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | 2026-08-12 | Traditional | PDF ↗ |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 | Traditional | PDF ↗ |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 | Traditional | PDF ↗ |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 | Traditional | PDF ↗ |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025-06-10 | Traditional | PDF ↗ |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | 2025-06-04 | Traditional | PDF ↗ |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 | Traditional | PDF ↗ |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 | Traditional | PDF ↗ |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 | Traditional | PDF ↗ |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 | Traditional | PDF ↗ |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 | Traditional | PDF ↗ |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 | Traditional | PDF ↗ |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 | Traditional | PDF ↗ |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 | Traditional | PDF ↗ |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 | Traditional | PDF ↗ |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 | Traditional | PDF ↗ |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | GE Healthcare Finland Oy | 2021-10-21 | Traditional | PDF ↗ |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Covidien | 2021-09-17 | Traditional | PDF ↗ |
| K201590 | EMMA Capnograph | Masimo Corporation | 2021-03-29 | Special | PDF ↗ |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | Unimed Medical Supplies, Inc. | 2021-03-04 | Traditional | PDF ↗ |
| K192488 | CO2 Sidestream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 | Traditional | PDF ↗ |
| K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 | Traditional | PDF ↗ |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2020-04-27 | Traditional | PDF ↗ |
| K192563 | Altera gas Sampling Lines | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 | Traditional | PDF ↗ |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | Bluepoint Medical GmbH & Co. KG | 2019-12-18 | Traditional | PDF ↗ |
| K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | 2019-05-23 | Traditional | PDF ↗ |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | GE Healthcare Finland Oy | 2019-05-01 | Special | PDF ↗ |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | Oridion Medical 1987 , Ltd. | 2019-03-22 | Traditional | PDF ↗ |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | Oridion Medical 1987 , Ltd. | 2019-02-08 | Traditional | PDF ↗ |
| K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 | Traditional | PDF ↗ |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | Medipines Corporation | 2019-01-11 | Traditional | PDF ↗ |
| K170820 | Capnograph and Oximeter | Cmi Health, Inc. | 2018-07-18 | Traditional | PDF ↗ |
| K173147 | SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. | 2018-06-20 | Traditional | PDF ↗ |
| K171828 | ETCO2 Sensor | Orantech, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | Vyaire Medical, Inc. | 2018-04-30 | Traditional | PDF ↗ |
| K172365 | Panoramic Oxygen Mask (POM) | Pom Medical, LLC | 2018-04-19 | Traditional | PDF ↗ |
| K171235 | OmniCap | Respirion, Inc. | 2018-01-04 | Traditional | PDF ↗ |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 | Traditional | PDF ↗ |
| K171765 | Nihon Kohden CO2 Monitor | Nihon Kohden Corporation | 2017-10-11 | Traditional | PDF ↗ |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | GE Healthcare Finland Oy | 2017-08-17 | Traditional | PDF ↗ |
| K161250 | OC-FLEX Flexible IntraOral Cannula | Venture Therapeutics, Inc. | 2017-03-17 | Traditional | PDF ↗ |
| K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corporation | 2017-02-24 | Traditional | PDF ↗ |
| K162343 | Westmed Gas Sampling Cannula with O2 delivery | Westmed, Inc. | 2016-12-14 | Traditional | PDF ↗ |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | Salter Labs | 2016-03-10 | Traditional | PDF ↗ |
| K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2015-07-17 | Traditional | PDF ↗ |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX | GE Healthcare Finland Oy | 2015-07-17 | Traditional | PDF ↗ |
| K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | Dispo-Med (Malaysia) Sdn Bhd | 2015-02-13 | Traditional | PDF ↗ |
| K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | 2015-02-12 | Special | PDF ↗ |
| K143150 | CO2 monitoring line with and without in-line filter | Besmed Health Business Corp | 2015-02-05 | Traditional | PDF ↗ |
| K142467 | IntelAir Nasal Airway Support System | Abeon Medical Corporation | 2014-11-24 | Special | PDF ↗ |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | Oridion Medical 1987 , Ltd. | 2014-08-05 | Traditional | PDF ↗ |
| K132946 | SOFTECH PLUS ETC02 CANNULA | Teleflexmedical, Inc. | 2014-06-04 | Traditional | PDF ↗ |
| K133516 | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER | Flexicare | 2014-04-30 | Traditional | PDF ↗ |
| K140473 | DUALGUARD | Flexicare Medical, Ltd. | 2014-04-10 | Traditional | PDF ↗ |
| K133540 | FLOCAP | Maxtec, Inc. | 2014-03-28 | Traditional | PDF ↗ |
| K131506 | AIRWAY SUPPORT SYSTEM / AIRPORT | Abeon Medical Corporation | 2014-03-06 | Traditional | PDF ↗ |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | Flexicare Medical, Ltd. | 2014-03-06 | Traditional | PDF ↗ |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | Southmedic, Inc. | 2014-01-13 | Traditional | PDF ↗ |
| K133806 | M1 CAPNOGRAPHY MASK | Monitor Mask, Inc. | 2013-12-31 | Traditional | PDF ↗ |
| K131339 | CAPNOMASK | Mediplus , Ltd. | 2013-11-25 | Traditional | PDF ↗ |
| K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | Nihon Kohden Corp. | 2013-05-21 | Traditional | PDF ↗ |
| K130112 | CAPNO MODULE, 92517 | Spacelabs Healthcare | 2013-03-21 | Special | PDF ↗ |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | Intersurgical, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K121927 | MICROSTREAM FILTERLINE ICU | Oridion Medical 1987 , Ltd. | 2012-11-29 | Traditional | PDF ↗ |
| K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | Phasein AB | 2012-10-25 | Special | PDF ↗ |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | Oridion Medical 1987 , Ltd. | 2012-07-19 | Traditional | PDF ↗ |
| K121017 | CAPNOGRAPHY PAD (92516) | Spacelabs Healthcare | 2012-07-13 | Special | PDF ↗ |
| K112840 | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | Seebreath AB | 2012-07-13 | Traditional | PDF ↗ |
| K120518 | END TIDAL CO2 NASAL CANNULA | Care Fusion | 2012-05-04 | Traditional | PDF ↗ |
| K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | Nihon Kohden Corp. | 2011-10-28 | Traditional | PDF ↗ |
| K103604 | ISA CO2, ISA AX+, ISA OR+ | Phasein AB | 2011-04-06 | Traditional | PDF ↗ |
| K094012 | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | Oridion Capnography, Inc. | 2010-05-12 | Special | PDF ↗ |
| K100941 | INFINITY MCABLE - MAINSTREAM CO2 | Draeger Medical AG & Co. KG | 2010-04-23 | Special | PDF ↗ |
| K093388 | SMART CAPNOLINE GUARDIAN | Oridion Medical 1987 , Ltd. | 2010-03-04 | Traditional | PDF ↗ |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | Ventlab Corp. | 2009-12-10 | Special | PDF ↗ |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | Nihon Kohden America, Inc. | 2009-03-02 | Special | PDF ↗ |
| K083056 | NEO-STAT CO2 <KG | Mercury Medical | 2009-02-23 | Traditional | PDF ↗ |
| K080527 | TWINGUARD WITH CAPNOGRAPH ACCESSORY | Trawax Pty Limited | 2008-10-31 | Traditional | PDF ↗ |
| K081601 | VEO MULTIGAS MONITOR FOR POCKET PC | Phasein AB | 2008-09-04 | Traditional | PDF ↗ |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | Ventlab Corp. | 2008-03-26 | Traditional | PDF ↗ |
| K072813 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | Phasein AB | 2007-12-28 | Traditional | PDF ↗ |
| K072843 | YG-125T AND YG-135T NASAL ADAPTER | Nihon Kohden America, Inc. | 2007-11-29 | Special | PDF ↗ |
| K072220 | PEDI CO2 EASY | Westmed, Inc. | 2007-08-23 | Traditional | PDF ↗ |
| K070128 | CO2 EASY | Westmed, Inc. | 2007-02-15 | Traditional | PDF ↗ |
| K063167 | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) | Phasein AB | 2007-02-06 | Traditional | PDF ↗ |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | Nihon Kohden America, Inc. | 2006-12-27 | Special | PDF ↗ |
| K053204 | INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006-02-03 | Special | PDF ↗ |
| K053174 | LOFLO C5 CO2 SENSOR | Respironics Novametrix, LLC | 2006-01-12 | Special | PDF ↗ |
| K053063 | PRO-FLOW MULTIPURPOSE CANNULA | Pro-Tech Services, Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K052880 | DATEX-OHMEDA S/5 INTERFACE MODULE E-INT | GE Healthcare | 2005-11-02 | Special | PDF ↗ |
| K052582 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES | GE Healthcare | 2005-10-14 | Special | PDF ↗ |
| K051857 | VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 | Weissburg Associates | 2005-09-15 | Traditional | PDF ↗ |
| K052167 | DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES | GE Healthcare | 2005-09-08 | Special | PDF ↗ |
| K050066 | C-CO2 COLORIMETRIC CO2 INDICATOR | Marquest Medical Products, Inc. | 2005-03-01 | Traditional | PDF ↗ |
| K042665 | SMART BITEBLOC | Oridion Medical 1987 , Ltd. | 2004-11-23 | Traditional | PDF ↗ |
| K042601 | CAPNOSTAT 5 | Respironics Novametrix, Inc. | 2004-11-19 | Special | PDF ↗ |
| K040875 | CAP-ONE, MODEL TG-920P | Nihon Kohden America, Inc. | 2004-10-15 | Traditional | PDF ↗ |
| K041956 | EMG - ESSENTIAL GAS MODULE, MODEL M1013A | Draeget Medical AG & Co. Kgaa | 2004-08-09 | Special | PDF ↗ |
| K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 | Respironics Novametrix, Inc. | 2004-06-18 | Special | PDF ↗ |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | Draeger Medical, Inc. | 2004-06-17 | Special | PDF ↗ |
Product code CCK · Class II · Anesthesiology. Data: openFDA.