WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K251802

510(k) cleared

STAR RF Ablation System

Merit Medical Systems, Inc. · Feb 13, 2026 · K251802

FDA cleared the STAR RF Ablation System from Merit Medical Systems, Inc. on Feb 13, 2026 under K251802, a traditional 510(k). The device falls under product code GXI, Probe, Radiofrequency Lesion, regulated at 21 CFR 882.4725 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 12, 2025. The decision came 246 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), K252892 (SCOUT MD Surgical Guidance System).

Questions & Answers

What did FDA clear under K251802?

K251802 is the FDA 510(k) for STAR RF Ablation System, submitted by Merit Medical Systems, Inc.. FDA's decision date was Feb 13, 2026, under product code GXI (Probe, Radiofrequency Lesion).

Who makes the STAR RF Ablation System?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K251802.

How long did the K251802 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Feb 13, 2026, 246 days later.

← All decisions in February 2026

Sources