CCK
- Product code
- CCK
- Device name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1400
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 307
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251641 | 2026-08-12 | Nihon Kohden Corporation | GF-310R Multigas Unit (GF-310R) | |
| K261633 | 2026-07-14 | Affirm Medical Technologies II, LLC | VisuBreath | FDA |
| K253030 | 2026-05-01 | Covidien, LLC | Capnostream35 Portable Respiratory Monitor (PM35MN) | |
| K250148 | 2025-08-28 | Prior Care Science Technology, Ltd. | Medical Gas Analyzer (AG200) | |
| K243956 | 2025-06-10 | Nihon Kohden Corporation | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Senso | |
| K251216 | 2025-06-04 | Barbaras Development, Inc. | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 013 | |
| K240937 | 2024-12-16 | Inventeur, LLC | AIM (N/A) | |
| K230915 | 2024-11-12 | Vyaire Medical, Inc. | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxyg | FDA |
| K212425 | 2024-11-07 | Exostat Medical, Inc. | MicroTrend System | |
| K222511 | 2023-11-21 | Southmedic, Inc. | Oxy2Pro | |
| K213767 | 2023-09-12 | Endure Industries, Inc. | Endure ETCO2/02 Nasal Cannula |
Official FDA classification page: CCK
Classification and pathway per current FDA publications. Data from openFDA (CC0).