# ODN: Ultrafiltration-Controlled Nocturnal 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)
- 2014: 1
- 2015: 1

## Most-cited predicates
- K141752: Nxstage System One (2014), cited by 3
- K150472: NxStage System One (2015), cited by 1

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