# MSE: Hemodialyzer, Re-Use, Low Flux

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 7
- 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)
- 1997: 3
- 1998: 2
- 1999: 1
- 2000: 1

## Most-cited predicates
- K974090: 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers (1998), cited by 1
- K983720: Asahi AM-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-Bio-50,AM-Bio-65, AM-Bio-75, and AM-Bio-100, AM-Bio- (1999), cited by 1
- K970650: Asahi AM-R Series Dialyzers (1997), cited by 1

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