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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 / June 2026 / K261442

510(k) cleared

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

Cadwell Industries, Inc. · Jun 26, 2026 · K261442

FDA cleared the Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array from Cadwell Industries, Inc. on Jun 26, 2026 under K261442, a abbreviated 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 Apr 30, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Cadwell Industries, Inc. has one other decision in the tracker over the last 12 months: K250851 (Hypnos (369054-200)).

Questions & Answers

What did FDA clear under K261442?

K261442 is the FDA 510(k) for Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array, submitted by Cadwell Industries, Inc.. FDA's decision date was Jun 26, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array?

Cadwell Industries, Inc., based in Kennewick, WA, is the applicant of record for K261442.

How long did the K261442 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Jun 26, 2026, 57 days later.

← All decisions in June 2026

Sources