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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 / April 2026 / K260988

510(k) cleared

°M Warmer System with °M Station

Mequ A/S · Apr 24, 2026 · K260988

FDA cleared the °M Warmer System with °M Station from Mequ A/S on Apr 24, 2026 under K260988, a special 510(k). The device falls under product code LGZ, Warmer, Thermal, Infusion Fluid, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 25, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mequ A/S in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260988?

K260988 is the FDA 510(k) for °M Warmer System with °M Station, submitted by Mequ A/S. FDA's decision date was Apr 24, 2026, under product code LGZ (Warmer, Thermal, Infusion Fluid).

Who makes the °M Warmer System with °M Station?

Mequ A/S, based in Copenhagen/Kobenhavn, is the applicant of record for K260988.

How long did the K260988 review take?

FDA received the submission on Mar 25, 2026 and issued its decision on Apr 24, 2026, 30 days later.

← All decisions in April 2026