# KPF: System, Dialysate Delivery, Semi-Automatic, Peritoneal

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1979: 3
- 1980: 2
- 1982: 1
- 1988: 2
- 1994: 1
- 1996: 1
- 1997: 1
- 1999: 1
- 2006: 1

## Most-cited predicates
- K061515: Renalsoft (2006), cited by 1
- K970989: Cyberren (1997), cited by 1
- K990953: Renal Link (1999), cited by 1

Source page: https://510kreport.com/product-code/KPF
Data by year (CSV): https://510kreport.com/product-code/KPF.csv