CCL · Class II · 21 CFR 868.1720

FDA Product Code CCL: Analyzer, Gas, Oxygen, Gaseous-phase

Leading manufacturers include Salter Labs, Hewlett-Packard Co. and Ohmeda Medical.

122
Total
122
Cleared
118d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 105d avg (recent)

FDA 510(k) Cleared Analyzer, Gas, Oxygen, Gaseous-phase Devices (Product Code CCL)

122 devices
1–24 of 122
Cleared Jul 30, 2026
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
K261389
Salter Labs
Anesthesiology · 93d
Cleared Aug 11, 2025
OxyMinder Pro (10310)
K251245
Bio-Med Device, Inc.
Anesthesiology · 111d
Cleared Apr 24, 2025
Smart Check O2 (MA0236)
K250002
Life Spark Medical, LLC
Anesthesiology · 112d
Cleared Apr 01, 2023
Maxtec MaxO2 ME+p
K221734
Maxtec, LLC
Anesthesiology · 290d
Cleared Aug 19, 2022
Percent Oxygen Sensors
K213933
Careox, LLC
Anesthesiology · 246d
Cleared Mar 17, 2022
OxyMinder
K213948
Bio-Med Devices, Inc.
Anesthesiology · 90d
Cleared May 02, 2018
Accu O2 Oxygen Analyzer
K173807
Precision Medical, Inc.
Anesthesiology · 138d
Cleared May 25, 2005
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
K051092
Ge Healthcare
Anesthesiology · 27d
Cleared Nov 03, 1999
SIEMENS FIO2 SENSOR
K991884
Siemens Medical Solutions USA, Inc.
Anesthesiology · 154d
Cleared Jul 09, 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295
Invacare Corp.
Anesthesiology · 220d
Cleared Aug 12, 1998
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619
Hewlett-Packard Co.
Anesthesiology · 16d
Cleared Aug 27, 1992
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338
Puritan Bennett Corp.
Anesthesiology · 216d
Cleared Mar 09, 1990
AG-820PA FI02 MODULE
K896359
Nihon Kohden America, Inc.
Anesthesiology · 123d
Cleared Jan 24, 1990
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
K896427
Spacelabs, Inc.
Anesthesiology · 77d
Cleared Oct 31, 1989
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
K894918
Mennen Medical, Inc.
Anesthesiology · 90d
Cleared Sep 12, 1988
MULTINEX MONITOR (MODIFICATION)
K883254
Datascope Corp.
Anesthesiology · 41d
Cleared Aug 24, 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743
Ohmeda Medical
Anesthesiology · 54d
Cleared Aug 19, 1988
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
K881663
Salter Labs
Anesthesiology · 126d
Cleared Jun 16, 1988
SL02 OXYGEN ANALYZER
K881472
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
SL01 OXYGEN ANALYZER
K881473
Salter Labs
Anesthesiology · 70d
Cleared May 02, 1986
SERVO GAS MONITOR 120
K861625
Siemens Elema AB
Anesthesiology · 3d
Cleared Oct 29, 1985
DMA OXYGEN MONITOR
K852823
Ferguson Medical
Anesthesiology · 120d
Cleared Jul 31, 1985
OHMEDA 5120 OXYGEN MONITOR
K853082
Ohmeda Medical
Anesthesiology · 8d
Cleared Apr 05, 1984
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K840645
Gambro, Inc.
Anesthesiology · 50d

About Product Code CCL - Regulatory Context

510(k) Submission Activity

122 total 510(k) submissions under product code CCL since 1976, with 122 receiving FDA clearance (average review time: 118 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CCL Product Code

FDA review times for CCL submissions have been consistent, averaging 105 days recently vs 119 days historically.

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