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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 / K254183

510(k) cleared

MR Conditional Cup Electrodes

Technomed Europe · May 7, 2026 · K254183

FDA cleared the MR Conditional Cup Electrodes from Technomed Europe on May 7, 2026 under K254183, a traditional 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 23, 2025. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Technomed Europe has one other decision in the tracker over the last 12 months: K253581 (Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)).

Questions & Answers

What did FDA clear under K254183?

K254183 is the FDA 510(k) for MR Conditional Cup Electrodes, submitted by Technomed Europe. FDA's decision date was May 7, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the MR Conditional Cup Electrodes?

Technomed Europe, based in Limburg, is the applicant of record for K254183.

How long did the K254183 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on May 7, 2026, 135 days later.

← All decisions in May 2026