# EXY: Uroflowmeter

- Device class: 2; regulation: 21 CFR 876.1800; FDA's rule: 510(k) exempt
- FDA decisions: 16
- Recalls: 1 (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
- 1987: 1
- 1988: 2
- 1989: 1
- 1990: 3
- 1994: 1
- 1995: 4
- 1997: 1
- 2003: 1
- 2014: 1

## Most-cited predicates
- K894968: Ultracompact (1989), cited by 1

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