# FKJ: Filter, Blood, Dialysis

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 5
- 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: 1
- 1982: 1
- 1984: 1
- 1990: 1
- 2026: 1

## Most-cited predicates
- K901734: Serim Residual Chlorine Test Kit (1990), cited by 2

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