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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 / K250632

510(k) cleared

Arctx Cool Catheter Set

Arctx Medical · Oct 30, 2025 · K250632

FDA cleared the Arctx Cool Catheter Set from Arctx Medical on Oct 30, 2025 under K250632, a traditional 510(k). The device falls under product code PLA, Esophageal Thermal Regulation And Gastric Suctioning Device, regulated at 21 CFR 870.5910 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 3, 2025. The decision came 241 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 Arctx Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250632?

K250632 is the FDA 510(k) for Arctx Cool Catheter Set, submitted by Arctx Medical. FDA's decision date was Oct 30, 2025, under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device).

Who makes the Arctx Cool Catheter Set?

Arctx Medical, based in Raleigh, NC, is the applicant of record for K250632.

How long did the K250632 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Oct 30, 2025, 241 days later.

← All decisions in October 2025