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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 / K252439

510(k) cleared

Tutamen Self Adhesive Electrodes

Dongguan Tutamen Metalwork Co., Ltd. · May 1, 2026 · K252439

FDA cleared the Tutamen Self Adhesive Electrodes from Dongguan Tutamen Metalwork Co., Ltd. on May 1, 2026 under K252439, 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 Aug 4, 2025. The decision came 270 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 Dongguan Tutamen Metalwork Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252439?

K252439 is the FDA 510(k) for Tutamen Self Adhesive Electrodes, submitted by Dongguan Tutamen Metalwork Co., Ltd.. FDA's decision date was May 1, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Tutamen Self Adhesive Electrodes?

Dongguan Tutamen Metalwork Co., Ltd., based in Dongguan, is the applicant of record for K252439.

How long did the K252439 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on May 1, 2026, 270 days later.

← All decisions in May 2026