KPF
13 FDA 510(k) clearances · Product code
101 daysmedian time to decision
226 days90th percentile
13clearances measured
FDA profile
- Official device name
- System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2001: 5 · 2002: 4 · 2003: 13 · 2004: 5 · 2005: 9 · 2006: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RENALSOFT (K061515) | Baxter Healthcare Corp | 2006-09-11 |
| RENAL LINK (K990953) | Baxter Healthcare Corp | 1999-06-18 |
| CYBERREN (K970989) | Cybernius Medical , Ltd. | 1997-07-24 |
| PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955762) | Fresenius USA, Inc. | 1996-07-31 |
| TOTAL CONTAINMENT DEVICE (K913515) | Denco | 1994-05-26 |
| AMICON EQUALINE FLUID BALANCE SYSTEM (K875121) | Amicon, Inc. | 1988-02-19 |
| ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE (K874020) | Abbott Laboratories | 1988-01-29 |
| C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (K821328) | Medionics International , Ltd. | 1982-07-28 |
| GAMBRO PERITONEAL DIALYSIS MONITOR (K802831) | Gambro, Inc. | 1980-12-18 |
| CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (K800496) | American Medical Products, Inc. | 1980-07-21 |
| PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (K791676) | J.M. Sounds Electronics Co. | 1979-12-06 |
| CYLER/HEATER FOR PERITONEAL DIALYSIS (K791584) | American Medical Products, Inc. | 1979-11-16 |
| AMP AUTOMATIC CYCLER STAND (K790091) | American Medical Products, Inc. | 1979-02-16 |
Track KPF automatically
Every clearance here is in the API, with alerts when new ones post.