# HHE: Cup, Menstrual

- Device class: 2; regulation: 21 CFR 884.5400; FDA's rule: 510(k) exempt
- FDA decisions: 16
- 510(k) review time 2021–2025: median 266 days (middle half 266–266)
- 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)
- 1997: 1
- 2002: 1
- 2005: 1
- 2006: 1
- 2008: 1
- 2009: 1
- 2010: 1
- 2012: 3
- 2014: 1
- 2024: 1

## Most-cited predicates
- K040335: Mooncup, Style a & B (2005), cited by 3
- K803250: Tassaway (1981), cited by 2
- K021356: The Divacup Menstrual Solution (2002), cited by 2
- K060852: Mooncup (2006), cited by 1
- K070965: Alicia Menstrual Cup (2008), cited by 1
- K092985: Bellecup (2010), cited by 1
- K870803: The Keeper (1987), cited by 1
- K971303: Instead, Softcup (1997), cited by 1
- K120107: Sckooncup (2012), cited by 1
- K091754: Lunette Menstrual Cup, Models 1 and 2 (2009), cited by 1

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