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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 / April 2026 / K252246

510(k) cleared

Leforte MMF System

Jeil Medical Corporation · Apr 2, 2026 · K252246

FDA cleared the Leforte MMF System from Jeil Medical Corporation on Apr 2, 2026 under K252246, a traditional 510(k). The device falls under product code JEY, Plate, Bone, regulated at 21 CFR 872.4760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 18, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jeil Medical Corporation has one other decision in the tracker over the last 12 months: K252826 (ARIX Femur Nail System).

Questions & Answers

What did FDA clear under K252246?

K252246 is the FDA 510(k) for Leforte MMF System, submitted by Jeil Medical Corporation. FDA's decision date was Apr 2, 2026, under product code JEY (Plate, Bone).

Who makes the Leforte MMF System?

Jeil Medical Corporation, based in Seoul, is the applicant of record for K252246.

How long did the K252246 review take?

FDA received the submission on Jul 18, 2025 and issued its decision on Apr 2, 2026, 258 days later.

← All decisions in April 2026