Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
FDA product code CCJ · Class II (moderate risk) · 21 CFR 868.1430 · Anesthesiology
28510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Bedfont Scientific, Ltd. 5
- Capnia, Inc. 4
- Vitalograph , Ltd. 2
- Mcneill Intl., Inc. 1
- Carrot, Inc. 1
- MD Diagnostics Limited 1
- Carrot Sense, Inc. 1
- Fim Medical 1
- Micro Direct, Inc. 1
- Bacharach, Inc. 1
- Pneumedics, Inc. 1
- Hewlett-Packard Co. 1
- Spirometrics, Inc. 1
- Bedfont Technical Instruments , Ltd. 1
- Erich Jaeger, Inc. 1
- Instrumentarium Corp. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Sherwood Medical Co. 1
- Ohio Medical Products 1
- Catalyst Research Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253119 | CoSense ETCO MonitorCCJ · Traditional | Capnia, Inc. | 05/29/2026SE |
| K211918 | iCOquit® Smokerlyzer®CCJ · Traditional | Bedfont Scientific, Ltd. | 12/21/2021SE |
| K201206 | Pivot Breath SensorCCJ · Traditional | Carrot, Inc. | 06/30/2021SE |
| K173238 | ToxCOCCJ · Traditional | Bedfont Scientific, Ltd. | 04/04/2019SE |
| K171129 | CO Check Pro, CO ScreenCCJ · Traditional | MD Diagnostics Limited | 03/02/2018SE |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS)CCJ · Traditional | Carrot Sense, Inc. | 09/29/2017SE |
| K151107 | CoSense ETCO MonitorCCJ · Special | Capnia, Inc. | 07/22/2015SE |
| K130036 | Cosense Co MonitorCCJ · Traditional | Capnia, Inc. | 01/14/2014SE |
| K121768 | CosenseCCJ · Traditional | Capnia, Inc. | 10/31/2012SE |
| K082315 | EC50 Micro+ SmokerlyzerCCJ · Traditional | Bedfont Scientific, Ltd. | 02/01/2010SE |
| K080278 | Tabataba CotesterCCJ · Traditional | Fim Medical | 11/28/2008SE |
| K070259 | EC50 Toxco+ Breath Carbon Monoxide MonitorCCJ · Traditional | Bedfont Scientific, Ltd. | 02/21/2008SE |
| K000962 | Pico Smokerlyzer, Model EC-50CCJ · Special | Bedfont Scientific, Ltd. | 04/20/2000SE |
| K950197 | MicrocoCCJ · Traditional | Micro Direct, Inc. | 10/17/1996SE |
| K952694 | Co Breath Analysis Module & Monoxol IICCJ · Traditional | Bacharach, Inc. | 01/29/1996SE |
| K904633 | Spiroloop, ModificationCCJ · Traditional | Pneumedics, Inc. | 03/12/1991SE |
| K902113 | Vitalograph - Breathco MonitorCCJ · Traditional | Mcneill Intl., Inc. | 10/26/1990SE |
| K900322 | CO/CMD-1CCJ · Traditional | Spirometrics, Inc. | 04/30/1990SE |
| K892841 | Bedfont EC50 Smokerlyzer Carbon Monoxide MonitorCCJ · Traditional | Bedfont Technical Instruments , Ltd. | 10/05/1989SE |
| K892524 | Vitalograph-Breathco MonitorCCJ · Traditional | Vitalograph , Ltd. | 05/05/1989SE |
| K863420 | Vitalograph EC-50 Carbon Monoxide MonitorCCJ · Traditional | Vitalograph , Ltd. | 01/15/1987SE |
| K843845 | Co TestCCJ · Traditional | Erich Jaeger, Inc. | 10/12/1984SE |
| K833739 | CD-102 Carbon Dioxide Analyzer/RecorCCJ · Traditional | Instrumentarium Corp. | 12/16/1983SE |
| K832655 | Ecolyzer #200/COHB Analyzer SysCCJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/26/1983SE |
| K802891 | Argyle Double Seal Chest Drainage UnitCCJ · Traditional | Sherwood Medical Co. | 12/19/1980SE |
| K781871 | Diffusion Option, Omni-LabCCJ · Traditional | Ohio Medical Products | 01/02/1979SE |
| K781746 | MinicoCCJ · Traditional | Catalyst Research Corp. | 12/05/1978SE |
| K760169 | Diffusion System, Single-Breath (47404A)CCJ · Traditional | Hewlett-Packard Co. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2198-2025 Class II | Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide…Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon… | Capnia Inc | 04/21/2025Open, Classified |