# LIF: Dialyzer Reprocessing System

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 57
- Recalls: 1 (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)
- 1996: 4
- 1997: 1
- 1998: 1
- 1999: 2
- 2000: 1
- 2002: 1
- 2003: 1
- 2004: 2
- 2005: 1
- 2010: 1

## Most-cited predicates
- K904210: Renatron II Dialyzer Reprocessing System RS 8330 (1990), cited by 5
- K860674: DRS-4 Dialyzer Reprocessing System (1986), cited by 2
- K834447: Echo MM1000 (1984), cited by 2
- K830575: Renalin (Tentative (1983), cited by 2
- K841153: Adaptor HR-3000 Reuse (1984), cited by 2
- K832230: Dialyzer Preparation Sys DPS-4 (1983), cited by 1
- K931336: DRS 4 Dialyzer Reprocessing System (1996), cited by 1
- K024076: Maky 21.1 Dialyzer Reprocessing System (2003), cited by 1
- K914580: DRS-4 Dialyzer Reprocessing System (1992), cited by 1
- K830190: Ahr-3000 RE-Use Adaptor (1983), cited by 1

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