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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 / May 2026 / K254073

510(k) cleared

StatSeal Disc

Merit Medical Systems, Inc. · May 13, 2026 · K254073

FDA cleared the StatSeal Disc from Merit Medical Systems, Inc. on May 13, 2026 under K254073, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 18, 2025. The decision came 146 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Merit Medical Systems, Inc. has 5 other decisions in the tracker over the last 12 months: K261310 (FlexTract Deflectable-Rotational Dilator Sheath Set), K262086 (PreludeSYNC Radial Compression Device), K251802 (STAR RF Ablation System), K252892 (SCOUT MD Surgical Guidance System).

Questions & Answers

What did FDA clear under K254073?

K254073 is the FDA 510(k) for StatSeal Disc, submitted by Merit Medical Systems, Inc.. FDA's decision date was May 13, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the StatSeal Disc?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K254073.

How long did the K254073 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on May 13, 2026, 146 days later.

← All decisions in May 2026

Sources