CAD · Class II · 21 CFR 868.5880

FDA Product Code CAD: Vaporizer, Anesthesia, Non-heated

Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

57
Total
57
Cleared
119d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 267d recently vs 116d historically

FDA 510(k) Cleared Vaporizer, Anesthesia, Non-heated Devices (Product Code CAD)

57 devices
1–24 of 57

About Product Code CAD - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code CAD since 1976, with 57 receiving FDA clearance (average review time: 119 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 CAD have taken an average of 267 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.

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