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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / DEN240080

510(k) cleared

Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated · Sep 23, 2025 · DEN240080

FDA cleared the Biolinq Shine Autonomous Time-in-Range Microsensor from Biolinq Incorporated on Sep 23, 2025 under DEN240080, a direct 510(k). The device falls under product code SFU, Glucose Range Monitoring System, regulated at 21 CFR 862.1359 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Dec 27, 2024. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Biolinq Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240080?

DEN240080 is the FDA 510(k) for Biolinq Shine Autonomous Time-in-Range Microsensor, submitted by Biolinq Incorporated. FDA's decision date was Sep 23, 2025, under product code SFU (Glucose Range Monitoring System).

Who makes the Biolinq Shine Autonomous Time-in-Range Microsensor?

Biolinq Incorporated, based in San Diego, CA, is the applicant of record for DEN240080.

How long did the DEN240080 review take?

FDA received the submission on Dec 27, 2024 and issued its decision on Sep 23, 2025, 270 days later.

← All decisions in September 2025