# MSF: Hemodialyzer, Re-Use, High Flux

- Device class: 2; regulation: 21 CFR 876.5860; 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)
- 1998: 6
- 2000: 1
- 2003: 1

## Most-cited predicates
- K970663: CT Celluloser Triacetate Hollow Fiber Dialyzer (CT-110G/CT-190G) (1998), cited by 2
- K994390: Gambro Polyflux 17R, Capillary Dialyzer/ Filter (2000), cited by 1
- K023615: Gambro Polyflux 6 LR, 8 LR and 10 LR (2003), cited by 1

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