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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 / K262086

510(k) cleared

PreludeSYNC Radial Compression Device

Merit Medical Systems, Inc. · Jul 22, 2026 · K262086

FDA cleared the PreludeSYNC Radial Compression Device from Merit Medical Systems, Inc. on Jul 22, 2026 under K262086, a special 510(k). The device falls under product code DXC, Clamp, Vascular, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 22, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Merit Medical Systems, Inc. has 5 other decisions in the tracker over the last 12 months: K261310 (FlexTract Deflectable-Rotational Dilator Sheath Set), K254073 (StatSeal Disc), K251802 (STAR RF Ablation System), K252892 (SCOUT MD Surgical Guidance System).

Questions & Answers

What did FDA clear under K262086?

K262086 is the FDA 510(k) for PreludeSYNC Radial Compression Device, submitted by Merit Medical Systems, Inc.. FDA's decision date was Jul 22, 2026, under product code DXC (Clamp, Vascular).

Who makes the PreludeSYNC Radial Compression Device?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K262086.

How long did the K262086 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Jul 22, 2026, 30 days later.

← All decisions in July 2026

Sources