FDA Product Code CCL: Analyzer, Gas, Oxygen, Gaseous-phase
Leading manufacturers include Maxtec, LLC, Life Spark Medical, LLC and Bio-Med Device, Inc..
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
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 Review Time
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 →