FDA Product Code CCL: Analyzer, Gas, Oxygen, Gaseous-phase
Leading manufacturers include Hewlett-Packard Co., Precision Medical, Inc. and Careox, LLC.
121
Total
121
Cleared
119d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
112d avg (recent)
FDA 510(k) Cleared Analyzer, Gas, Oxygen, Gaseous-phase Devices (Product Code CCL)
121 devices
Cleared
Aug 11, 2025
OxyMinder Pro (10310)
Bio-Med Device, Inc.
Anesthesiology
111d
Cleared
Apr 24, 2025
Smart Check O2 (MA0236)
Life Spark Medical, LLC
Anesthesiology
112d
Cleared
Apr 01, 2023
Maxtec MaxO2 ME+p
Maxtec, LLC
Anesthesiology
290d
Cleared
Aug 19, 2022
Percent Oxygen Sensors
Careox, LLC
Anesthesiology
246d
Cleared
Mar 17, 2022
OxyMinder
Bio-Med Devices, Inc.
Anesthesiology
90d
Cleared
May 02, 2018
Accu O2 Oxygen Analyzer
Precision Medical, Inc.
Anesthesiology
138d
Cleared
Nov 03, 1999
SIEMENS FIO2 SENSOR
Siemens Medical Solutions USA, Inc.
Anesthesiology
154d
Cleared
Aug 12, 1998
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
Hewlett-Packard Co.
Anesthesiology
16d
Cleared
Feb 09, 1983
OPTION A02 MODEL 15202A
Hewlett-Packard Co.
Anesthesiology
30d
Cleared
Dec 09, 1982
OXYGEN MONITOR IL 408
Instrumentation Laboratory CO
Anesthesiology
27d
Cleared
Feb 17, 1977
MONITOR, OXYGEN, MODEL 78216C
Hewlett-Packard Co.
Anesthesiology
17d
About Product Code CCL - Regulatory Context
510(k) Submission Activity
121 total 510(k) submissions under product code CCL since 1976, with 121 receiving FDA clearance (average review time: 119 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - CCL Product Code
FDA review times for CCL submissions have been consistent, averaging 112 days recently vs 119 days historically.
CCL devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →