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 / April 2026 / K252708

510(k) cleared

Relu Cloud

Relu BV · Apr 10, 2026 · K252708

FDA cleared the Relu Cloud from Relu BV on Apr 10, 2026 under K252708, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 27, 2025. The decision came 226 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 Relu BV in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252708?

K252708 is the FDA 510(k) for Relu Cloud, submitted by Relu BV. FDA's decision date was Apr 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Relu Cloud?

Relu BV, based in Leuven, is the applicant of record for K252708.

How long did the K252708 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Apr 10, 2026, 226 days later.

← All decisions in April 2026