# HHI: System, Abortion, Vacuum

- Device class: 2; regulation: 21 CFR 884.5070; FDA's rule: 510(k) required
- FDA decisions: 24
- 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)
- 1984: 6
- 1985: 1
- 1986: 1
- 1987: 3
- 1988: 1
- 1990: 3
- 1994: 1
- 1998: 1
- 2003: 1
- 2017: 1

## Most-cited predicates
- K030935: Berkeley V-10 Vacuum Curettage System (2003), cited by 3
- K813282: Synevac Vacuum Curettage Systems (1981), cited by 2
- K840383: Menstrual Aspiration Kit (1984), cited by 1

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