# FIL: System, Dialysate Delivery, Single Pass

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1977: 3
- 1978: 1
- 1979: 1
- 1989: 1
- 1990: 1
- 2002: 1

## Most-cited predicates
- K011741: Crit-Line Monitor Iii Tqa (CLM Tqa) (2002), cited by 1

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