# MBU: Single-Use Internal Condom

- Device class: 2; regulation: 21 CFR 884.5340; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1993: 2
- 1994: 2
- 1995: 10
- 1997: 1
- 2009: 1
- 2011: 1
- 2017: 1

## Most-cited predicates

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