Data / Medical devices / United States / Biolinq Incorporated
Biolinq Incorporated: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Biolinq Incorporated is registered with the FDA (registration 3025798257) in San Diego, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025798257
- Address
- 10260 Sorrento Valley Rd, San Diego, CA, United States, 92121
- Owner or operator
- Biolinq Incorporated (10094164)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 17, 2025
- Registered through
- 2027
- Brand names listed
- Biolinq Shine Autonomous Time-in-Range Microsensor, Biolinq Shine Sensor Cover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Range Monitoring System | SFU | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 23, 2025 | DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | SFU | Unknown | Biolinq Incorporated | accessdata.fda.gov |
Compare with other makers
Updated September 23, 2025. 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.