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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 / May 2026 / K260295

510(k) cleared

Helio Kids; Apex P

Motion Composites · May 28, 2026 · K260295

FDA cleared the Helio Kids; Apex P from Motion Composites on May 28, 2026 under K260295, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jan 29, 2026. The decision came 119 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 Motion Composites in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260295?

K260295 is the FDA 510(k) for Helio Kids; Apex P, submitted by Motion Composites. FDA's decision date was May 28, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Helio Kids; Apex P?

Motion Composites, based in Saint-Roch-DelAchigan, is the applicant of record for K260295.

How long did the K260295 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on May 28, 2026, 119 days later.

← All decisions in May 2026