FDA Product Code KPM: Shunt, Peritoneal
Leading manufacturers include Codman & Shurtleff, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and 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
Cleared
Aug 18, 2023
Automatic Continuous Effusion Shunt (ACES) System ACES System
Pleural Dynamics, Inc.
Gastroenterology & Urology
122d
Cleared
Aug 21, 1990
LEVEEN PERITINEO-VENOUS SHUNT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology
151d
Cleared
Sep 29, 1989
DENVER PERITONEO-VENUS SHUNT
Codman & Shurtleff, Inc.
Gastroenterology & Urology
64d
Cleared
Jun 20, 1988
DENVER PLEURO-PERITONEAL SHUNT
Codman & Shurtleff, Inc.
Gastroenterology & Urology
131d
Cleared
May 31, 1988
DENVER PERITONEO-VENOUS SHUNT
Codman & Shurtleff, Inc.
Gastroenterology & Urology
123d
Cleared
Jan 15, 1981
CORDIS HAKIM ASCITES VALVE SYSTEM
Cordis Corp.
Gastroenterology & Urology
23d
Cleared
Apr 15, 1977
VALVE, ASCITES, LAVEEN
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology
16d
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.