FDA Product Code DRS: Transducer, Blood-pressure, Extravascular
Leading manufacturers include Edwards Lifesciences, LLC.
FDA 510(k) Cleared Transducer, Blood-pressure, Extravascular Devices (Product Code DRS)
About Product Code DRS - Regulatory Context
510(k) Submission Activity
148 total 510(k) submissions under product code DRS since 1977, with 148 receiving FDA clearance (average review time: 103 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under DRS have taken an average of 178 days to reach a decision - up from 102 days historically. Manufacturers should account for longer review timelines in current project planning.
DRS devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →