KPF · Class II · 21 CFR 876.5630

FDA Product Code KPF: System, Dialysate Delivery, Semi-automatic, Peritoneal

Leading manufacturers include American Medical Products, Inc., Baxter Healthcare Corp and Gambro, Inc..

13
Total
13
Cleared
172d
Avg days
1979
Since

FDA 510(k) Cleared System, Dialysate Delivery, Semi-automatic, Peritoneal Devices (Product Code KPF)

13 devices
1–13 of 13
Cleared Sep 11, 2006
RENALSOFT
K061515
Baxter Healthcare Corp
Gastroenterology & Urology · 102d
Cleared Jun 18, 1999
RENAL LINK
K990953
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jul 24, 1997
CYBERREN
K970989
Cybernius Medical , Ltd.
Gastroenterology & Urology · 128d
Cleared Jul 31, 1996
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762
Fresenius USA, Inc.
Gastroenterology & Urology · 226d
Cleared Feb 19, 1988
AMICON EQUALINE FLUID BALANCE SYSTEM
K875121
Amicon, Inc.
Gastroenterology & Urology · 66d
Cleared Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020
Abbott Laboratories
Gastroenterology & Urology · 119d
Cleared Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831
Gambro, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 21, 1980
CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
K800496
American Medical Products, Inc.
Gastroenterology & Urology · 139d
Cleared Nov 16, 1979
CYLER/HEATER FOR PERITONEAL DIALYSIS
K791584
American Medical Products, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 16, 1979
AMP AUTOMATIC CYCLER STAND
K790091
American Medical Products, Inc.
Gastroenterology & Urology · 31d

About Product Code KPF - Regulatory Context