CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class II
FDA Device Classification
Classification Details
- Product Code
- CCK
- Device Class
- Class II
- Regulation Number
- 868.1400
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250148 | prior care science technology | Medical Gas Analyzer (AG200) | August 28, 2025 |
| K243956 | nihon kohden corporation | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | June 10, 2025 |
| K251216 | barbaras development | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO | June 4, 2025 |
| K240937 | inventeur | AIM (N/A) | December 16, 2024 |
| K230915 | vyaire medical | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | November 12, 2024 |
| K212425 | exostat medical | MicroTrend System | November 7, 2024 |
| K222511 | southmedic | Oxy2Pro | November 21, 2023 |
| K213767 | endure industries | Endure ETCO2/02 Nasal Cannula | September 12, 2023 |
| K221118 | draegerwerk ag and co kgaa | CO2 Mainstream Sensor | April 5, 2023 |
| K210112 | pneuma therapeutics | XChange Device, XChange System | January 30, 2023 |
| K220533 | engineered medical systems | Endoscopy Oxygen Mask | November 16, 2022 |
| K213911 | covidien | Microstream CO2 NanoPod | July 29, 2022 |
| K213518 | covidien | CARESCAPE CO2 Microstream parameter | April 12, 2022 |
| K211171 | ge healthcare finland | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiO | October 21, 2021 |
| K203762 | covidien | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric C | September 17, 2021 |
| K201590 | masimo corporation | EMMA Capnograph | March 29, 2021 |
| K210019 | unimed medical supplies | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model C | March 4, 2021 |
| K192488 | beijing kingst commercial and trade co | CO2 Sidestream Module | May 22, 2020 |
| K192446 | beijing kingst commercial and trade co | CO2 Mainstream Module | May 21, 2020 |
| K200594 | oridion medical 1987 | Capnostream 35 Portable Respiratory Monitor | April 27, 2020 |