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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 / July 2026 / K261081

510(k) cleared

Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

Beijing Konted Medical Technology Co.,Ltd · Jul 23, 2026 · K261081

FDA cleared the Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) from Beijing Konted Medical Technology Co.,Ltd on Jul 23, 2026 under K261081, a special 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 Apr 1, 2026. The decision came 113 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 Beijing Konted Medical Technology Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261081?

K261081 is the FDA 510(k) for Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro), submitted by Beijing Konted Medical Technology Co.,Ltd. FDA's decision date was Jul 23, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)?

Beijing Konted Medical Technology Co.,Ltd, based in Beijing, is the applicant of record for K261081.

How long did the K261081 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jul 23, 2026, 113 days later.

← All decisions in July 2026