DWA · Class II · 21 CFR 870.4380

FDA Product Code DWA: Control, Pump Speed, Cardiopulmonary Bypass

Leading manufacturers include Inspira Technologies Oxy B.H.N. , Ltd..

37
Total
37
Cleared
115d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 256d recently vs 111d historically

FDA 510(k) Cleared Control, Pump Speed, Cardiopulmonary Bypass Devices (Product Code DWA)

37 devices
1–24 of 37
Cleared May 24, 2024
INSPIRA ART100
K232788
Inspira Technologies Oxy B.H.N. , Ltd.
Cardiovascular · 256d

About Product Code DWA - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code DWA since 1978, with 37 receiving FDA clearance (average review time: 115 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA Review Time

Recent submissions under DWA have taken an average of 256 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.

DWA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →