FDA Product Code CAW: Generator, Oxygen, Portable
Leading manufacturers include Jiangsu Yuyue Medical Equipment& Supply Co., Ltd., Qingdao Kingon Medical Science and Technology Co., Ltd. and Devilbiss Healthcare, LLC.
FDA 510(k) Cleared Generator, Oxygen, Portable Devices (Product Code CAW)
About Product Code CAW - Regulatory Context
510(k) Submission Activity
285 total 510(k) submissions under product code CAW since 1976, with 285 receiving FDA clearance (average review time: 143 days).
Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under CAW have taken an average of 202 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.
CAW devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →