System, Dialysate Delivery, Semi-Automatic, Peritoneal

FDA product code KPF · Class II (moderate risk) · 21 CFR 876.5630 · Gastroenterology, Urology

13510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K061515RenalsoftKPF · Traditional Baxter Healthcare Corp09/11/2006SE
K990953Renal LinkKPF · Traditional Baxter Healthcare Corp06/18/1999SE
K970989CyberrenKPF · Traditional Cybernius Medical , Ltd.07/24/1997SE
K955762Packpd Peritoneal Dialysis Urea Kinetic Modeling Software ProgramKPF · Traditional Fresenius USA, Inc.07/31/1996SE
K913515Total Containment DeviceKPF · Traditional Denco05/26/1994SE
K875121Amicon Equaline Fluid Balance SystemKPF · Traditional Amicon, Inc.02/19/1988SE
K874020Ultracare(Tm) Automated Patient Assist DeviceKPF · Traditional Abbott Laboratories01/29/1988SE
K821328C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional Medionics International , Ltd.07/28/1982SE
K802831Gambro Peritoneal Dialysis MonitorKPF · Traditional Gambro, Inc.12/18/1980SE
K800496Cycler W/5 or 10 Hr. Fill/Dwell TimerKPF · Traditional American Medical Products, Inc.07/21/1980SE
K791676Peritoneal Dialysis Cycler Model PDC1000KPF · Traditional J.M. Sounds Electronics Co.12/06/1979SE
K791584Cyler/Heater for Peritoneal DialysisKPF · Traditional American Medical Products, Inc.11/16/1979SE
K790091Amp Automatic Cycler StandKPF · Traditional American Medical Products, Inc.02/16/1979SE

Recalls

RecallProductFirmInitiated
Z-0528-2008 Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data…Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post… Baxter Healthcare Renal Div11/14/2007Terminated
Z-0527-2008 Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data…Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post… Baxter Healthcare Renal Div11/14/2007Terminated