FDA applicant
Biolinq Incorporated
FDA records 2 decisions for Biolinq Incorporated (San Diego, CA) from 2025 to 2026: 1 510(k) clearance and 1 De Novo grant. All are in product code SFU (Glucose Range Monitoring System). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biolinq Incorporated’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Biolinq Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report