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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 / March 2026 / K260453

510(k) cleared

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

Bionit Labs Srl · Mar 12, 2026 · K260453

FDA cleared the Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) from Bionit Labs Srl on Mar 12, 2026 under K260453, a special 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 Feb 11, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bionit Labs Srl in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260453?

K260453 is the FDA 510(k) for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60), submitted by Bionit Labs Srl. FDA's decision date was Mar 12, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

Bionit Labs Srl, based in Soleto, is the applicant of record for K260453.

How long did the K260453 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Mar 12, 2026, 29 days later.

← All decisions in March 2026