CO2 Mainstream Sensor
FDA 510(k) clearance K221118 · decided 2023-04-05
Clearance details
- K-number
- K221118
- Device name
- CO2 Mainstream Sensor
- Applicant
- Draegerwerk AG & CO Kgaa
- Decision
- Substantially Equivalent
- Date received
- 2022-04-18
- Decision date
- 2023-04-05
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Draegerwerk AG & CO Kgaa
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VisuBreath (K261633) | Affirm Medical Technologies II, LLC | 2026-07-14 |
| Capnostream™35 Portable Respiratory Monitor (PM35MN) (K253030) | Covidien, LLC | 2026-05-01 |
| Medical Gas Analyzer (AG200) (K250148) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956) | Nihon Kohden Corporation | 2025-06-10 |
| 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216) | Barbaras Development, Inc. | 2025-06-04 |
| AIM (N/A) (K240937) | Inventeur, LLC | 2024-12-16 |
| AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (K230915) | Vyaire Medical, Inc. | 2024-11-12 |
| MicroTrend System (K212425) | Exostat Medical, Inc. | 2024-11-07 |
| Oxy2Pro (K222511) | Southmedic, Inc. | 2023-11-21 |
| Endure ETCO2/02 Nasal Cannula (K213767) | Endure Industries, Inc. | 2023-09-12 |
| XChange Device, XChange System (K210112) | Pneuma Therapeutics, Inc. | 2023-01-30 |
| Endoscopy Oxygen Mask (K220533) | Engineered Medical Systems, Inc. | 2022-11-16 |
Recalls involving this device
No recalls on record reference this clearance.