# LTF: Stimulator, Salivary System

- Device class: 2; regulation: 21 CFR 872.5560; FDA's rule: 510(k) required
- FDA decisions: 3
- 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
- 2017: 1
- 2018: 1

## Most-cited predicates
- K180838: SaliPen (2018), cited by 2
- K160799: GenNarino (2017), cited by 1
- P860067: Salitron System (1988), cited by 1

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