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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 / K261256

510(k) cleared

Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

Shenzhen Magnet Technology Co., Ltd. · Jun 11, 2026 · K261256

FDA cleared the Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) from Shenzhen Magnet Technology Co., Ltd. on Jun 11, 2026 under K261256, a traditional 510(k). The device falls under product code LXB, Hearing Aid, Bone Conduction, regulated at 21 CFR 874.3302 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 16, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Magnet Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261256?

K261256 is the FDA 510(k) for Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3), submitted by Shenzhen Magnet Technology Co., Ltd.. FDA's decision date was Jun 11, 2026, under product code LXB (Hearing Aid, Bone Conduction).

Who makes the Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)?

Shenzhen Magnet Technology Co., Ltd., based in Shenzhen, is the applicant of record for K261256.

How long did the K261256 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Jun 11, 2026, 56 days later.

← All decisions in June 2026