# NWO: Kit, Catheter, Urinary (Exludes Hiv Testing)

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 1

## Most-cited predicates
- K071496: Icath, Sterilesure (2007), cited by 1

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