# FKT: System, Dialysate Delivery, Sorbent Regenerated

- Device class: 2; regulation: 21 CFR 876.5600; FDA's rule: 510(k) required
- FDA decisions: 19
- Recalls: 0 (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)
- 1986: 1
- 1987: 1
- 1988: 2
- 1996: 1
- 2003: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2010: 1
- 2013: 1

## Most-cited predicates
- K070739: Allient Sorbent Hemodialysis System, Model# 1500 (2007), cited by 2
- K811170: D-3160 Sorbent Cartridge (1981), cited by 1
- K043574: Allient Sorbent Hemodialysis System, Model 1000 (2005), cited by 1
- K812869: D-3260 Sorbent Cartridge (1981), cited by 1
- K093362: 2008 Hemodialysis Sorbent System (2010), cited by 1
- K882428: REDY 2000 (1988), cited by 1

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