Product code CCK
- Device name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1400
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | 2025-06-10 |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | 2025-06-04 |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 |
| 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 |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Covidien | 2021-09-17 |
| K201590 | EMMA Capnograph | Masimo Corporation | 2021-03-29 |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | Unimed Medical Supplies, Inc. | 2021-03-04 |
| K192488 | CO2 Sidestream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 |
| K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2020-04-27 |
| K192563 | Altera gas Sampling Lines | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 |
| 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/Pe... | Bluepoint Medical GmbH & Co. KG | 2019-12-18 |
| K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | 2019-05-23 |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | GE Healthcare Finland Oy | 2019-05-01 |
| 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... | Oridion Medical 1987 , Ltd. | 2019-03-22 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | Oridion Medical 1987 , Ltd. | 2019-02-08 |
| K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | Medipines Corporation | 2019-01-11 |
| K170820 | Capnograph and Oximeter | Cmi Health, Inc. | 2018-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3944670047010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700068020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700064010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700063010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700051020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048100 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048090 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048080 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048070 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048060 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048050 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048030 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3944060056010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945000030010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300046010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945600013020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048040 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| 09555866301385 | DISPO-MED | DISPO-MED (MALAYSIA) SDN. BHD. | 2026-04-02 |
| 09555866300869 | DISPO-MED | DISPO-MED (MALAYSIA) SDN. BHD. | 2025-08-01 |
| 09555866301019 | Dispo-Med | DISPO-MED (MALAYSIA) SDN. BHD. | 2023-01-06 |
| 10080196729005 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-14 |
| 10190752113923 | AirLife™ | AIRLIFE | 2020-01-17 |
| 10190752113930 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752113763 | Vital Signs™ | VYAIRE MEDICAL, INC. | 2019-12-20 |
| 10080196551361 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196551477 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |