# ONW: Hemodialysis System For Home Use

- Device class: 2; regulation: 21 CFR 876.5860; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 92 days (middle half 92–92)
- Recalls: 4 (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)
- 2011: 1
- 2013: 2
- 2024: 1

## Most-cited predicates
- K124035: 2008K@Home Hemodialysis Machine (2013), cited by 2
- K070049: Fresenius 2008K @Home with Wireless Wetness Detector (2011), cited by 1
- K121421: Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) (2013), cited by 1

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