# ETF: Unit, Examining/Treatment, Ent

- Device class: 1; regulation: 21 CFR 874.5300; FDA's rule: 510(k) exempt
- FDA decisions: 32
- 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)
- 1980: 8
- 1981: 1
- 1982: 6
- 1984: 2
- 1986: 2
- 1988: 1
- 1990: 2
- 1991: 3
- 1993: 1
- 1995: 2

## Most-cited predicates

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