# HGY: Pump, Breast, Non-Powered

- Device class: 1; regulation: 21 CFR 884.5150; FDA's rule: 510(k) exempt
- FDA decisions: 27
- 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)
- 1984: 3
- 1985: 3
- 1990: 1
- 1993: 1
- 1994: 1
- 1995: 2
- 1997: 2
- 2001: 2
- 2004: 1
- 2010: 1

## Most-cited predicates
- K823591: Ameda Hand Breast Pump (1982), cited by 1
- K823840: Medela Namual Breast Pump (1983), cited by 1
- K011519: Ameda Hygienikit (2001), cited by 1

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