Data / Medical devices / United States / Blueocean Global Corp
Blueocean Global Corp: FDA-registered device maker in Southold, NY, United States, 1 510(k) clearance
Blueocean Global Corp is registered with the FDA (registration 3028117759) in Southold, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3028117759
- Address
- 370 Koke Drive, Southold, NY, United States, 11971
- Owner or operator
- BlueOcean Global Corp (10088550)
- Roles
- Specification developer
- First device listed
- January 23, 2026
- Registered through
- 2027
- Brand names listed
- Excelsior System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2026 | K253291 | Excelsior System | KTT | Substantially Equivalent | Blue Ocean Global | accessdata.fda.gov |
Compare with other makers
Updated January 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.