# LZI: Device, Assistive Listening

- Device class: 2; regulation: 21 CFR 874.3320; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 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)
- 1991: 1
- 1994: 1
- 1995: 2
- 1997: 2
- 2004: 1

## Most-cited predicates
- K043090: Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field Systems (2004), cited by 1

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