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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 / October 2025 / K250955

510(k) cleared

XC11 ICE System, USA

Yorlabs, Inc. · Oct 22, 2025 · K250955

FDA cleared the XC11 ICE System, USA from Yorlabs, Inc. on Oct 22, 2025 under K250955, a traditional 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 31, 2025. The decision came 205 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 Yorlabs, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250955?

K250955 is the FDA 510(k) for XC11 ICE System, USA, submitted by Yorlabs, Inc.. FDA's decision date was Oct 22, 2025, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the XC11 ICE System, USA?

Yorlabs, Inc., based in Carlsbad, CA, is the applicant of record for K250955.

How long did the K250955 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Oct 22, 2025, 205 days later.

← All decisions in October 2025