CCL · Class II · 21 CFR 868.1720

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

Leading manufacturers include Salter Labs, Ceramatec, Inc. and Vascular Technology Incorporated.

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 Nov 25, 2008
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101
K082655
Envitec-Wismar GmbH
Anesthesiology · 74d
Cleared Jan 03, 2008
DIGIFLO CONCENTRATOR ANALYZER
K072469
Digiflo, Inc.
Anesthesiology · 121d
Cleared Feb 27, 2007
PRECISION OXYGEN MONITOR
K063096
Precision Medical, Inc.
Anesthesiology · 140d
Cleared Feb 22, 2007
MAXO2 CU
K063488
Maxtec, Inc.
Anesthesiology · 97d
Cleared Apr 05, 2006
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
K053407
Analytical Industries, Inc.
Anesthesiology · 119d
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 Jun 09, 2004
MAXO2+, MODEL A AND AE
K040484
Maxtec, Inc.
Anesthesiology · 105d
Cleared Jul 17, 2003
MX 300 OXYGEN MONITOR
K024155
Teledyne Analytical Instruments
Anesthesiology · 212d
Cleared Jul 17, 2003
RX300 OXYGEN ANALYZER
K024228
Teledyne Analytical Instruments
Anesthesiology · 206d
Cleared Mar 28, 2003
OXICHECK
K023565
Caradyne, Ltd.
Anesthesiology · 156d
Cleared Jul 23, 2001
PRIMA OXYGEN MONITOR
K010318
Penlon , Ltd.
Anesthesiology · 171d
Cleared Mar 14, 2001
'ALL 2000' % OXYGEN ANALYZER
K002382
Analytical Industries, Inc.
Anesthesiology · 222d

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 →