# LWF: Dilator, Nasal

- Device class: 1; regulation: 21 CFR 874.3900; FDA's rule: 510(k) exempt
- FDA decisions: 20
- 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)
- 1988: 1
- 1991: 1
- 1993: 1
- 1995: 6
- 1996: 4
- 1997: 1
- 1998: 1
- 2004: 1
- 2012: 1
- 2018: 1

## Most-cited predicates
- K120665: Invent Snoring Device (2012), cited by 1

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