# FKQ: System, Dialysate Delivery, Central Multiple Patient

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 61
- 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)
- 1981: 5
- 1982: 8
- 1983: 3
- 1984: 15
- 1985: 9
- 1986: 7
- 1987: 4
- 1988: 1
- 1989: 1
- 2006: 1

## Most-cited predicates
- K854391: Hemodialysis Concentrate (1986), cited by 1
- K861730: Actril for Kidney Machine Disinfectant (1987), cited by 1
- K852310: Naturalyte Bicarbonate Concentrate-Dry Pack (1985), cited by 1
- K873421: Kawasumi a.V. Fistula Set (1987), cited by 1
- K843963: Dialysate Concentrate for Hemodialysis-Liquid/Powd (1985), cited by 1

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