# NII: Disinfectant, Dialysate Delivery System

- Device class: 2; regulation: 21 CFR 876.5860; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2004: 1
- 2005: 1

## Most-cited predicates
- K043207: Ozone Generator (2005), cited by 2
- K023064: Hemoclean (2004), cited by 1

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