FDA Product Code DSB: Plethysmograph, Impedance
Leading manufacturers include Zynex Medical, Inc., ImpediMed Limited and Mode Sensors AS.
FDA 510(k) Cleared Plethysmograph, Impedance Devices (Product Code DSB)
About Product Code DSB - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code DSB since 1977, with 114 receiving FDA clearance (average review time: 187 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under DSB have taken an average of 250 days to reach a decision - up from 186 days historically. Manufacturers should account for longer review timelines in current project planning.
DSB devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →