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 / November 2025 / K250635

510(k) cleared

FEops HEARTguide Simulation Application

Feops NV · Nov 25, 2025 · K250635

FDA cleared the FEops HEARTguide Simulation Application from Feops NV on Nov 25, 2025 under K250635, a traditional 510(k). The device falls under product code QQI, Interventional Cardiovascular Implant Simulation Software Device, regulated at 21 CFR 870.1405 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 3, 2025. The decision came 267 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 Feops NV in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250635?

K250635 is the FDA 510(k) for FEops HEARTguide Simulation Application, submitted by Feops NV. FDA's decision date was Nov 25, 2025, under product code QQI (Interventional Cardiovascular Implant Simulation Software Device).

Who makes the FEops HEARTguide Simulation Application?

Feops NV, based in Gent, is the applicant of record for K250635.

How long did the K250635 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Nov 25, 2025, 267 days later.

← All decisions in November 2025