KPM · Class II · 21 CFR 876.5955

FDA Product Code KPM: Shunt, Peritoneal

Leading manufacturers include Codman & Shurtleff, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Denver Biomaterials, 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
1–19 of 19
Cleared Aug 18, 2023
Automatic Continuous Effusion Shunt (ACES) System ACES System
K231096
Pleural Dynamics, Inc.
Gastroenterology & Urology · 122d
Cleared Nov 02, 2017
BD Curve Ascites Shunt
K170405
Care Fusion
Gastroenterology & Urology · 265d
Cleared Oct 04, 2001
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K012235
Denver Biomedical, Inc.
Gastroenterology & Urology · 79d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862
Denver Biomedical, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020
Denver Biomedicals, Inc.
Gastroenterology & Urology · 58d
Cleared Jan 02, 2001
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
K003451
Denver Biomedicals, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 17, 1998
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS
K973129
Denver Biomaterials, Inc.
Gastroenterology & Urology · 208d
Cleared Apr 14, 1997
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814
Denver Biomaterials, Inc.
Gastroenterology & Urology · 269d
Cleared Aug 21, 1990
LEVEEN PERITINEO-VENOUS SHUNT
K901360
Bd Becton Dickinson Vacutainer Systems Preanalytic
Gastroenterology & Urology · 151d
Cleared Sep 29, 1989
DENVER PERITONEO-VENUS SHUNT
K894756
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 64d
Cleared Jun 20, 1988
DENVER PLEURO-PERITONEAL SHUNT
K880570
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 131d
Cleared May 31, 1988
DENVER PERITONEO-VENOUS SHUNT
K880401
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 123d
Cleared Jan 15, 1981
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Apr 15, 1977
VALVE, ASCITES, LAVEEN
K770602
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.