# MLW: Warmer, Peritoneal Dialysate

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 445 days (middle half 445–445)
- 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)
- 1994: 1
- 1997: 1
- 1999: 1
- 2002: 1
- 2013: 1
- 2025: 1

## Most-cited predicates
- K993330: Thermochem-HT System (1999), cited by 3

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