# FII: System, Dialysate Delivery, Sealed

- Device class: 2; regulation: 21 CFR 876.5860; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 2 (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)
- 1982: 1
- 1986: 1
- 1987: 1
- 1988: 1
- 2003: 1

## Most-cited predicates
- K872364: Hemodialysis (SPS), Model 550, Code 5M1309 (1987), cited by 1
- K881270: Gambro Multipurpose System MPS-10 (1988), cited by 1
- K030470: Nxstage System One (2003), cited by 1

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