# NUI: Ultrasound, Infusion, System

- Device class: 2; regulation: 21 CFR 870.1200; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 2005: 2
- 2006: 2

## Most-cited predicates
- K053437: Ekos Micro-Infusion System (2006), cited by 3
- K062508: Neurowave Micro-Infusion System (2006), cited by 3
- K051225: Ekos Micro-Infusion System (2005), cited by 2
- K041826: Ekos Ultrasound Infusion System (2005), cited by 1

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