# FJG: Dialyzer, Parallel Flow

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 36
- 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: 4
- 1979: 6
- 1980: 6
- 1981: 8
- 1982: 1
- 1986: 2
- 1990: 2
- 1992: 2
- 1994: 2

## Most-cited predicates

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