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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 / September 2025 / K250331

510(k) cleared

Astrasono A3Pro Bladder Scanner (A3Pro)

Astrasono Technology Co., Ltd. · Sep 30, 2025 · K250331

FDA cleared the Astrasono A3Pro Bladder Scanner (A3Pro) from Astrasono Technology Co., Ltd. on Sep 30, 2025 under K250331, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 5, 2025. The decision came 237 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 Astrasono Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250331?

K250331 is the FDA 510(k) for Astrasono A3Pro Bladder Scanner (A3Pro), submitted by Astrasono Technology Co., Ltd.. FDA's decision date was Sep 30, 2025, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the Astrasono A3Pro Bladder Scanner (A3Pro)?

Astrasono Technology Co., Ltd., based in Shenzhen, is the applicant of record for K250331.

How long did the K250331 review take?

FDA received the submission on Feb 5, 2025 and issued its decision on Sep 30, 2025, 237 days later.

← All decisions in September 2025