CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class II
FDA product code CCK covers "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase", a Class II medical device regulated under 21 CFR 868.1400. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261633 | affirm medical technologies ii | VisuBreath | July 14, 2026 |
| K253030 | covidien | Capnostream35 Portable Respiratory Monitor (PM35MN) | May 1, 2026 |
| 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 |