iCOquit® Smokerlyzer®
FDA 510(k) clearance K211918 · decided 2021-12-21
Clearance details
- K-number
- K211918
- Device name
- iCOquit® Smokerlyzer®
- Applicant
- Bedfont Scientific, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-21
- Decision date
- 2021-12-21
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- CCJ
- Device class
- 2
- Regulation number
- 868.1430
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Maidstone, Kent, GB
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CoSense ETCO Monitor (K253119) | Capnia, Inc. | 2026-05-29 |
| Pivot Breath Sensor (K201206) | Carrot, Inc. | 2021-06-30 |
| ToxCO (K173238) | Bedfont Scientific, Ltd. | 2019-04-04 |
| CO Check Pro, CO Screen (K171129) | MD Diagnostics Limited | 2018-03-02 |
| Carbon Monoxide Breath Sensor System (COBSS) (K171408) | Carrot Sense, Inc. | 2017-09-29 |
| CoSense ETCO Monitor (K151107) | Capnia, Inc. | 2015-07-22 |
| COSENSE CO MONITOR (K130036) | Capnia, Inc. | 2014-01-14 |
| COSENSE (K121768) | Capnia, Inc. | 2012-10-31 |
| EC50 MICRO+ SMOKERLYZER (K082315) | Bedfont Scientific, Ltd. | 2010-02-01 |
| TABATABA COTESTER (K080278) | Fim Medical | 2008-11-28 |
| EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (K070259) | Bedfont Scientific, Ltd. | 2008-02-21 |
| PICO SMOKERLYZER, MODEL EC-50 (K000962) | Bedfont Scientific, Ltd. | 2000-04-20 |
Recalls involving this device
No recalls on record reference this clearance.