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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 / July 2026 / K261644

510(k) cleared

Perfadex Plus

Xvivo Perfusion AB · Jul 23, 2026 · K261644

FDA cleared the Perfadex Plus from Xvivo Perfusion AB on Jul 23, 2026 under K261644, a traditional 510(k). The device falls under product code KDN, System, Perfusion, Kidney, regulated at 21 CFR 876.5880 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 18, 2026. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xvivo Perfusion AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261644?

K261644 is the FDA 510(k) for Perfadex Plus, submitted by Xvivo Perfusion AB. FDA's decision date was Jul 23, 2026, under product code KDN (System, Perfusion, Kidney).

Who makes the Perfadex Plus?

Xvivo Perfusion AB, based in Mölndal, is the applicant of record for K261644.

How long did the K261644 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jul 23, 2026, 66 days later.

← All decisions in July 2026