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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 / K252812

510(k) cleared

UniPearls® Embolic Microspheres

Suzhou Haowei Medical Technology Co., Ltd. · Jul 31, 2026 · K252812

FDA cleared the UniPearls® Embolic Microspheres from Suzhou Haowei Medical Technology Co., Ltd. on Jul 31, 2026 under K252812, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 4, 2025. The decision came 330 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 Suzhou Haowei Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252812?

K252812 is the FDA 510(k) for UniPearls® Embolic Microspheres, submitted by Suzhou Haowei Medical Technology Co., Ltd.. FDA's decision date was Jul 31, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the UniPearls® Embolic Microspheres?

Suzhou Haowei Medical Technology Co., Ltd., based in Suzhou, is the applicant of record for K252812.

How long did the K252812 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Jul 31, 2026, 330 days later.

← All decisions in July 2026