FDA Product Code DPW: Flowmeter, Blood, Cardiovascular
Leading manufacturers include Remington Medical, Inc., Flosonics Medical and Elfi-Tech , Ltd..
FDA 510(k) Cleared Flowmeter, Blood, Cardiovascular Devices (Product Code DPW)
About Product Code DPW - Regulatory Context
510(k) Submission Activity
137 total 510(k) submissions under product code DPW since 1976, with 137 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DPW have taken an average of 133 days to reach a decision - down from 166 days historically, suggesting improved FDA processing for this classification.
DPW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →