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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 / October 2025 / K252357

510(k) cleared

Glucose2

Abbott Ireland · Oct 24, 2025 · K252357

FDA cleared the Glucose2 from Abbott Ireland on Oct 24, 2025 under K252357, a traditional 510(k). The device falls under product code CFR, Hexokinase, Glucose, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 29, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Abbott Ireland in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252357?

K252357 is the FDA 510(k) for Glucose2, submitted by Abbott Ireland. FDA's decision date was Oct 24, 2025, under product code CFR (Hexokinase, Glucose).

Who makes the Glucose2?

Abbott Ireland, based in Longford, is the applicant of record for K252357.

How long did the K252357 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Oct 24, 2025, 87 days later.

← All decisions in October 2025