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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 / December 2025 / K252892

510(k) cleared

SCOUT MD Surgical Guidance System

Merit Medical Systems, Inc. · Dec 19, 2025 · K252892

FDA cleared the SCOUT MD Surgical Guidance System from Merit Medical Systems, Inc. on Dec 19, 2025 under K252892, a traditional 510(k). The device falls under product code NEU, Marker, Radiographic, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 11, 2025. The decision came 99 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), K254073 (StatSeal Disc), K251802 (STAR RF Ablation System).

Questions & Answers

What did FDA clear under K252892?

K252892 is the FDA 510(k) for SCOUT MD Surgical Guidance System, submitted by Merit Medical Systems, Inc.. FDA's decision date was Dec 19, 2025, under product code NEU (Marker, Radiographic, Implantable).

Who makes the SCOUT MD Surgical Guidance System?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K252892.

How long did the K252892 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Dec 19, 2025, 99 days later.

← All decisions in December 2025

Sources