FDA Product Code KPM: Shunt, Peritoneal
Leading manufacturers include Pleural Dynamics, Inc..
19
Total
19
Cleared
147d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Shunt, Peritoneal Devices (Product Code KPM)
19 devices
About Product Code KPM - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code KPM since 1977, with 19 receiving FDA clearance (average review time: 147 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
KPM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →