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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085. Terminated |
KPF | K061515 |
| Jan 26, 2008 | Baxter Healthcare Renal Div Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K061515 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| May 3, 2006 | Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illin Terminated |
KPF | K990953 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Terminated |
KPF | K990953 |
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