Product Code: CCJ FDA class 2 21 CFR 868.1430

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

The Gaseous-Phase Carbon-Monoxide Analyzer is an anesthesiology device that measures the concentration of carbon monoxide in the gas phase of a breathing system, used to detect dangerous levels of CO in inspired gases and protect patients from carbon monoxide exposure. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCJ, regulated under 21 CFR 868.1430, within the Anesthesiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: CCJ
Device Class: FDA class 2
Regulation Number: 868.1430
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253119	CoSense ETCO Monitor	May 29, 2026	Substantially Equivalent	Capnia, Inc.
K211918	iCOquit® Smokerlyzer®	Dec 21, 2021	Substantially Equivalent	Bedfont Scientific, Ltd.
K201206	Pivot Breath Sensor	Jun 30, 2021	Substantially Equivalent	Carrot, Inc.
K173238	ToxCO	Apr 04, 2019	Substantially Equivalent	Bedfont Scientific, Ltd.
K171129	CO Check Pro, CO Screen	Mar 02, 2018	Substantially Equivalent	MD Diagnostics Limited
K171408	Carbon Monoxide Breath Sensor System (COBSS)	Sep 29, 2017	Substantially Equivalent	Carrot Sense, Inc.
K151107	CoSense ETCO Monitor	Jul 22, 2015	Substantially Equivalent	Capnia, Inc.
K130036	COSENSE CO MONITOR	Jan 14, 2014	Substantially Equivalent	Capnia, Inc.
K121768	COSENSE	Oct 31, 2012	Substantially Equivalent	Capnia, Inc.
K082315	EC50 MICRO+ SMOKERLYZER	Feb 01, 2010	Substantially Equivalent	Bedfont Scientific, Ltd.
K080278	TABATABA COTESTER	Nov 28, 2008	Substantially Equivalent	Fim Medical
K070259	EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR	Feb 21, 2008	Substantially Equivalent	Bedfont Scientific, Ltd.
K000962	PICO SMOKERLYZER, MODEL EC-50	Apr 20, 2000	Substantially Equivalent	Bedfont Scientific, Ltd.
K950197	MICROCO	Oct 17, 1996	Substantially Equivalent	Micro Direct, Inc.
K952694	CO BREATH ANALYSIS MODULE & MONOXOL II	Jan 29, 1996	Substantially Equivalent	Bacharach, Inc.
K904633	SPIROLOOP, MODIFICATION	Mar 12, 1991	Substantially Equivalent	Pneumedics, Inc.
K902113	VITALOGRAPH - BREATHCO MONITOR	Oct 26, 1990	Substantially Equivalent	Mcneill Intl., Inc.
K900322	CO/CMD-1	Apr 30, 1990	Substantially Equivalent	Spirometrics, Inc.
K892841	BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR	Oct 05, 1989	Substantially Equivalent	Bedfont Technical Instruments , Ltd.
K892524	VITALOGRAPH-BREATHCO MONITOR	May 05, 1989	Substantially Equivalent	Vitalograph , Ltd.
K863420	VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR	Jan 15, 1987	Substantially Equivalent	Vitalograph , Ltd.
K843845	CO TEST	Oct 12, 1984	Substantially Equivalent	Erich Jaeger, Inc.
K833739	CD-102 CARBON DIOXIDE ANALYZER/RECOR	Dec 16, 1983	Substantially Equivalent	Instrumentarium Corp.
K832655	ECOLYZER #200/COHB ANALYZER SYS	Sep 26, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802891	ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT	Dec 19, 1980	Substantially Equivalent	Sherwood Medical Co.
K781871	DIFFUSION OPTION, OMNI-LAB	Jan 02, 1979	Substantially Equivalent	Ohio Medical Products
K781746	MINICO	Dec 05, 1978	Substantially Equivalent	Catalyst Research Corp.
K760169	DIFFUSION SYSTEM, SINGLE-BREATH (47404A)	Jul 20, 1976	Substantially Equivalent	Hewlett-Packard Co.