CCT · Class II · 21 CFR 868.5170

FDA Product Code CCT: Applicator (laryngo-tracheal), Topical Anesthesia

Leading manufacturers include Dualams, Inc., Dba Airkor.

10
Total
10
Cleared
171d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 274d recently vs 159d historically

FDA 510(k) Cleared Applicator (laryngo-tracheal), Topical Anesthesia Devices (Product Code CCT)

10 devices
1–10 of 10
Cleared Oct 16, 2024
UltraEzAir® (UEA1A)
K240114
Dualams, Inc., Dba Airkor
Anesthesiology · 274d

About Product Code CCT - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code CCT since 1976, with 10 receiving FDA clearance (average review time: 171 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under CCT have taken an average of 274 days to reach a decision - up from 159 days historically. Manufacturers should account for longer review timelines in current project planning.

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