CCJ · Class II · 21 CFR 868.1430

FDA Product Code CCJ: Analyzer, Gas, Carbon-monoxide, Gaseous-phase

Leading manufacturers include Bedfont Scientific, Ltd., Capnia, Inc. and Vitalograph , Ltd..

28
Total
28
Cleared
200d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 247d recently vs 198d historically

FDA 510(k) Cleared Analyzer, Gas, Carbon-monoxide, Gaseous-phase Devices (Product Code CCJ)

28 devices
1–24 of 28
Cleared May 29, 2026
CoSense ETCO Monitor
K253119
Capnia, Inc.
Anesthesiology · 247d
Cleared Dec 21, 2021
iCOquit® Smokerlyzer®
K211918
Bedfont Scientific, Ltd.
Toxicology · 183d
Cleared Jun 30, 2021
Pivot Breath Sensor
K201206
Carrot, Inc.
Toxicology · 422d
Cleared Apr 04, 2019
ToxCO
K173238
Bedfont Scientific, Ltd.
Anesthesiology · 546d
Cleared Mar 02, 2018
CO Check Pro, CO Screen
K171129
MD Diagnostics Limited
Anesthesiology · 319d
Cleared Sep 29, 2017
Carbon Monoxide Breath Sensor System (COBSS)
K171408
Carrot Sense, Inc.
Toxicology · 140d
Cleared Jul 22, 2015
CoSense ETCO Monitor
K151107
Capnia, Inc.
Anesthesiology · 86d
Cleared Jan 14, 2014
COSENSE CO MONITOR
K130036
Capnia, Inc.
Anesthesiology · 372d
Cleared Oct 31, 2012
COSENSE
K121768
Capnia, Inc.
Anesthesiology · 138d
Cleared Feb 01, 2010
EC50 MICRO+ SMOKERLYZER
K082315
Bedfont Scientific, Ltd.
Toxicology · 537d
Cleared Nov 28, 2008
TABATABA COTESTER
K080278
Fim Medical
Anesthesiology · 298d
Cleared Feb 21, 2008
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
K070259
Bedfont Scientific, Ltd.
Anesthesiology · 391d
Cleared Oct 17, 1996
MICROCO
K950197
Micro Direct, Inc.
Anesthesiology · 638d
Cleared Jan 29, 1996
CO BREATH ANALYSIS MODULE & MONOXOL II
K952694
Bacharach, Inc.
Anesthesiology · 229d
Cleared May 05, 1989
VITALOGRAPH-BREATHCO MONITOR
K892524
Vitalograph , Ltd.
Anesthesiology · 24d
Cleared Jan 15, 1987
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420
Vitalograph , Ltd.
Anesthesiology · 133d
Cleared Oct 12, 1984
CO TEST
K843845
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Dec 16, 1983
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K833739
Instrumentarium Corp.
Anesthesiology · 52d
Cleared Sep 26, 1983
ECOLYZER #200/COHB ANALYZER SYS
K832655
Bd Becton Dickinson Vacutainer Systems Preanalytic
Anesthesiology · 49d
Cleared Dec 19, 1980
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891
Sherwood Medical Co.
Anesthesiology · 32d
Cleared Jan 02, 1979
DIFFUSION OPTION, OMNI-LAB
K781871
Ohio Medical Products
Anesthesiology · 60d
Cleared Jul 20, 1976
DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
K760169
Hewlett-Packard Co.
Anesthesiology · 14d

About Product Code CCJ - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code CCJ since 1976, with 28 receiving FDA clearance (average review time: 200 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CCJ Product Code

Recent submissions under CCJ have taken an average of 247 days to reach a decision - up from 198 days historically. Manufacturers should account for longer review timelines in current project planning.

CCJ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →