# FMA: Depressor, Tongue, Non-Surgical

- Device class: 1; regulation: 21 CFR 880.6230; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1977: 1
- 1982: 1
- 1983: 1
- 1984: 1
- 1999: 1

## Most-cited predicates
- K842461: Tongue Depressor (1984), cited by 1

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