Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1430](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1430) → CCJ — Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase # CCJ · Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase _Anesthesiology · 21 CFR 868.1430 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ ## Overview - **Product Code:** CCJ - **Device Name:** Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase - **Regulation:** [21 CFR 868.1430](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1430) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K211918](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K211918.md) | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | Dec 21, 2021 | SESE | | [K201206](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K201206.md) | Pivot Breath Sensor | Carrot, Inc. | Jun 30, 2021 | SESE | | [K173238](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K173238.md) | ToxCO | Bedfont Scientific, Ltd. | Apr 4, 2019 | SESE | | [K171129](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K171129.md) | CO Check Pro, CO Screen | MD Diagnostics Limited | Mar 2, 2018 | SESE | | [K171408](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K171408.md) | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | Sep 29, 2017 | SESE | | [K151107](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K151107.md) | CoSense ETCO Monitor | Capnia, Inc. | Jul 22, 2015 | SESE | | [K130036](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K130036.md) | COSENSE CO MONITOR | Capnia, Inc. | Jan 14, 2014 | SESE | | [K121768](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K121768.md) | COSENSE | Capnia, Inc. | Oct 31, 2012 | SESE | | [K082315](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K082315.md) | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | Feb 1, 2010 | SESE | | [K080278](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K080278.md) | TABATABA COTESTER | Fim Medical | Nov 28, 2008 | SESE | | [K070259](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K070259.md) | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | Feb 21, 2008 | SESE | | [K000962](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K000962.md) | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | Apr 20, 2000 | SESE | | [K950197](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K950197.md) | MICROCO | Micro Direct, Inc. | Oct 17, 1996 | SESE | | [K952694](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K952694.md) | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | Jan 29, 1996 | SESE | | [K904633](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K904633.md) | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | Mar 12, 1991 | SESE | | [K902113](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K902113.md) | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | Oct 26, 1990 | SESE | | [K900322](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K900322.md) | CO/CMD-1 | Spirometrics, Inc. | Apr 30, 1990 | SESE | | [K892841](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K892841.md) | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Bedfont Technical Instruments , Ltd. | Oct 5, 1989 | SESE | | [K892524](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K892524.md) | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | May 5, 1989 | SESE | | [K863420](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K863420.md) | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | Jan 15, 1987 | SESE | ## Top Applicants - Bedfont Scientific, Ltd. — 5 clearances - Capnia, Inc. — 3 clearances - Vitalograph , Ltd. — 2 clearances - Bacharach, Inc. — 1 clearance - Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com