# MSC: Barrier, Std, Oral Sex

- Device class: 2; regulation: 21 CFR 884.5300; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 227 days (middle half 224–249)
- 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)
- 1998: 1
- 1999: 1
- 2010: 1
- 2021: 1
- 2022: 2
- 2026: 1

## Most-cited predicates
- K091769: Trust Dam (2010), cited by 3
- K212928: Lorals (2022), cited by 1
- K990067: Sheer Glyde Dams (1999), cited by 1

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