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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 / December 2025 / K251152

510(k) cleared

DBLG2

Diabeloop · Dec 19, 2025 · K251152

FDA cleared the DBLG2 from Diabeloop on Dec 19, 2025 under K251152, a traditional 510(k). The device falls under product code QJI, Interoperable Automated Glycemic Controller, regulated at 21 CFR 862.1356 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 14, 2025. The decision came 249 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 Diabeloop in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251152?

K251152 is the FDA 510(k) for DBLG2, submitted by Diabeloop. FDA's decision date was Dec 19, 2025, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the DBLG2?

Diabeloop, based in Grenoble, is the applicant of record for K251152.

How long did the K251152 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Dec 19, 2025, 249 days later.

← All decisions in December 2025