# Biolinq Incorporated

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2025–2026): 1 510(k) clearance and 1 De Novo grant
- Product codes: SFU (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor (2025), cited by 1

## Recent decisions
- K262599: Biolinq Shine Autonomous Time-in-Range Microsensor (Sep 18, 2026)
- DEN240080: Biolinq Shine Autonomous Time-in-Range Microsensor (Sep 23, 2025)

Source page: https://510kreport.com/company/biolinq