# FKR: Subsystem, Proportioning

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1978: 1
- 1980: 2
- 1981: 2
- 1985: 2
- 2005: 1
- 2006: 1
- 2008: 1
- 2011: 1
- 2014: 1

## Most-cited predicates
- K043436: Nxstage Dialysate Preparation Module, Model NX0269 (2005), cited by 2
- K080919: Nxstage Pureflow SL (2008), cited by 1
- K810127: Gambro Bicarbonate Module, BCM-10 (1981), cited by 1
- K060296: Nxstage Dialysate Preparation Module (2006), cited by 1
- K111174: Nxstage Pureflow SL (2011), cited by 1

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