CCL · Class II · 21 CFR 868.1720

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

Leading manufacturers include Salter Labs, Maxtec, LLC and Hewlett-Packard Co..

122
Total
122
Cleared
118d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 1 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 Jun 10, 2016
MaxO2ME
K153659
Maxtec, LLC
Anesthesiology · 172d
Cleared Feb 28, 2013
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195
GE Healthcare Finland Oy
Anesthesiology · 140d
Cleared Jan 23, 2013
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
K122290
Envitec-Wismar GmbH
Anesthesiology · 177d
Cleared Dec 14, 2011
ULTRAMAXO2 OXYGEN ANALYER
K112402
Maxtec, LLC
Anesthesiology · 114d
Cleared Feb 27, 2007
PRECISION OXYGEN MONITOR
K063096
Precision Medical, Inc.
Anesthesiology · 140d
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 Jul 15, 2004
OXYGEN MEDICELS, CITICELS
K041773
City Technology Limited
Anesthesiology · 14d
Cleared Feb 03, 2000
TED 200T7 OXYGEN MONITOR
K990403
Teledyne Electronic Technologies
Anesthesiology · 359d
Cleared Nov 09, 1999
TED 60T OXYGEN ANALYZER
K990457
Teledyne Electronic Technologies
Anesthesiology · 270d
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 Mar 17, 1999
PRO2 CHECK OXYGEN INDICATOR
K983500
Medical Technology Specialists, Inc.
Anesthesiology · 162d
Cleared Aug 12, 1998
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619
Hewlett-Packard Co.
Anesthesiology · 16d
Cleared Jul 21, 1998
MODEL 02 OXYGEN ANALYZER
K971084
Oxigraf, Inc.
Anesthesiology · 483d
Cleared May 26, 1998
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K973545
Vacumed, Div. of Vacumetrics, Inc.
Anesthesiology · 250d
Cleared Mar 30, 1998
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
K972992
Ceramatec, Inc.
Anesthesiology · 230d
Cleared Mar 04, 1998
HANDI OXYGEN ANALYZER
K973282
Ceramatec, Inc.
Anesthesiology · 183d

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 1 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 →