Panels › Gastroenterology, Urology › Product code KPF · Class 2
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Regulation 876.5630
0510(k)s in 12 months (13 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in KPF
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Renal Div | 0 | 7 |
| American Medical Products, Inc. | 3 | 0 |
| Baxter Healthcare Corp | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Amicon, Inc. | 1 | 0 |
| Cybernius Medical , Ltd. | 1 | 0 |
| Denco | 1 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| Gambro, Inc. | 1 | 0 |
| J.M. Sounds Electronics Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2006 | K061515 | RENALSOFT Baxter Healthcare Corp | KPF |
| Jun 18, 1999 | K990953 | RENAL LINK Baxter Healthcare Corp | KPF |
| Jul 24, 1997 | K970989 | CYBERREN Cybernius Medical , Ltd., CA | KPF |
| Jul 31, 1996 | K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM Fresenius USA, Inc. | KPF |
| May 26, 1994 | K913515 | TOTAL CONTAINMENT DEVICE Denco | KPF |
| Feb 19, 1988 | K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM Amicon, Inc. | KPF |
| Jan 29, 1988 | K874020 | ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE Abbott Laboratories | KPF |
| Jul 28, 1982 | K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP Medionics International , Ltd. | KPF |
| Dec 18, 1980 | K802831 | GAMBRO PERITONEAL DIALYSIS MONITOR Gambro, Inc. | KPF |
| Jul 21, 1980 | K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER American Medical Products, Inc. | KPF |
| Dec 6, 1979 | K791676 | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 J.M. Sounds Electronics Co. | KPF |
| Nov 16, 1979 | K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS American Medical Products, Inc. | KPF |
| Feb 16, 1979 | K790091 | AMP AUTOMATIC CYCLER STAND American Medical Products, Inc. | KPF |
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