# NRB: Wound Cleaner, Ultrasound

- Device class: 2; regulation: 21 CFR 878.4410; FDA's rule: 510(k) required
- FDA decisions: 9
- 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
- 2009: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 2
- 2016: 1

## Most-cited predicates
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), cited by 2
- K050129: Celleration Mist Therapy System 5.1 (2005), cited by 2
- DEN040004: Celleration Mist Therapy System (2004), cited by 1
- K140782: Ultramist System, Ultramist Generator, Ultramist Treatment Wand, Ultramist Applicator (2014), cited by 1
- K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12 (2012), cited by 1

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