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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 / April 2026 / K252709

510(k) cleared

Wireless Probe Type Ultrasound Scanner

Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Apr 2, 2026 · K252709

FDA cleared the Wireless Probe Type Ultrasound Scanner from Xuzhou Yongkang Electronic Science Technology Co., Ltd. on Apr 2, 2026 under K252709, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 27, 2025. The decision came 218 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 Xuzhou Yongkang Electronic Science Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252709?

K252709 is the FDA 510(k) for Wireless Probe Type Ultrasound Scanner, submitted by Xuzhou Yongkang Electronic Science Technology Co., Ltd.. FDA's decision date was Apr 2, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Wireless Probe Type Ultrasound Scanner?

Xuzhou Yongkang Electronic Science Technology Co., Ltd., based in Xuzhou, is the applicant of record for K252709.

How long did the K252709 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Apr 2, 2026, 218 days later.

← All decisions in April 2026