# OCO: Mouthguard, Migraine/Tension Headache

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 296 days (middle half 296–296)
- 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)
- 2001: 1
- 2016: 1
- 2021: 1

## Most-cited predicates
- K010876: Nti Tension Suppression System (2001), cited by 6
- K160477: The Luco Hybrid OSA Appliance (2016), cited by 1

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