# Blue Ocean Global

- Location (FDA's records): Miami, FL
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: KTT (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Sequel Medical, Inc.: 1 (https://510kreport.com/company/sequel-medical)

## Recent decisions
- K253291: Excelsior System (Jan 20, 2026)

Source page: https://510kreport.com/company/blue-ocean-global