# HFS: Shield, Nipple

- Device class: 1; regulation: 21 CFR 880.5630; FDA's rule: 510(k) exempt
- FDA decisions: 12
- 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)
- 1981: 1
- 1983: 1
- 1984: 1
- 1985: 1
- 1986: 2
- 1993: 2
- 1994: 4

## Most-cited predicates

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