# HIO: Sampler, Amniotic Fluid (Amniocentesis Tray)

- Device class: 1; regulation: 21 CFR 884.1550; FDA's rule: 510(k) exempt
- FDA decisions: 20
- 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)
- 1980: 1
- 1983: 1
- 1985: 2
- 1986: 2
- 1989: 3
- 1990: 3
- 1991: 1
- 1992: 3
- 1993: 1
- 1996: 2

## Most-cited predicates
- K914419: Amniotest (TM) (1993), cited by 2

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