# FKP: System, Dialysate Delivery, Single Patient

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 50
- Recalls: 12 (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)
- 1994: 1
- 1995: 2
- 1996: 2
- 1997: 1
- 1999: 1
- 2001: 1
- 2002: 1
- 2004: 1
- 2013: 2
- 2018: 1

## Most-cited predicates
- K910215: Drake Willock System 1000 Dialysate Delivery Syst (1991), cited by 4
- K873155: Gambro Bicart System (1987), cited by 3
- K890824: Fresenius 2008 Touch Panel Control Dialysis System (1989), cited by 2
- K921456: Fresenius 3008/FDS-08 Dialysate Delivery System (1994), cited by 2
- K854367: HD-Secura Hemadialysis Machine (1985), cited by 1
- K964264: High Range Peroxide Test Strip (1997), cited by 1
- K021060: Fresenius Icare Monitoring System (2002), cited by 1
- K883111: Heomdialysis Single Patient System (SPS) Model 650 (1989), cited by 1
- K922757: SPS 1550 Single Needle Patient System (1995), cited by 1
- K955423: Pack H Hemodialysis Urea Kinetic Modeling Software Program (1996), cited by 1

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