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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 / K252790

510(k) cleared

Digital ClarusScope System and Digital NeuroPEN System

Clarus Medical, LLC · May 26, 2026 · K252790

FDA cleared the Digital ClarusScope System and Digital NeuroPEN System from Clarus Medical, LLC on May 26, 2026 under K252790, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 2, 2025. The decision came 266 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 Clarus Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252790?

K252790 is the FDA 510(k) for Digital ClarusScope System and Digital NeuroPEN System, submitted by Clarus Medical, LLC. FDA's decision date was May 26, 2026, under product code HRX (Arthroscope).

Who makes the Digital ClarusScope System and Digital NeuroPEN System?

Clarus Medical, LLC, based in Minneapolis, MN, is the applicant of record for K252790.

How long did the K252790 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on May 26, 2026, 266 days later.

← All decisions in May 2026