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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 / K252238

510(k) cleared

CoroFlow Cardiovascular System

Coroventis Research AB · Oct 24, 2025 · K252238

FDA cleared the CoroFlow Cardiovascular System from Coroventis Research AB on Oct 24, 2025 under K252238, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 17, 2025. The decision came 99 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 Coroventis Research AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252238?

K252238 is the FDA 510(k) for CoroFlow Cardiovascular System, submitted by Coroventis Research AB. FDA's decision date was Oct 24, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the CoroFlow Cardiovascular System?

Coroventis Research AB, based in Uppsala, is the applicant of record for K252238.

How long did the K252238 review take?

FDA received the submission on Jul 17, 2025 and issued its decision on Oct 24, 2025, 99 days later.

← All decisions in October 2025