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 / June 2026 / K260456

510(k) cleared

VI°Port Liver Preservation System

Traferox Technologies, Inc. · Jun 1, 2026 · K260456 · In the directory

FDA cleared the VI°Port Liver Preservation System from Traferox Technologies, Inc. on Jun 1, 2026 under K260456, 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 Feb 11, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Traferox Technologies, Inc. has one other decision in the tracker over the last 12 months: P250025 (TorEx Lung Perfusion System).

Questions & Answers

What did FDA clear under K260456?

K260456 is the FDA 510(k) for VI°Port Liver Preservation System, submitted by Traferox Technologies, Inc.. FDA's decision date was Jun 1, 2026, under product code KDN (System, Perfusion, Kidney).

Who makes the VI°Port Liver Preservation System?

Traferox Technologies, Inc., based in Mississauga, is the applicant of record for K260456. The company is listed in the MedDevice Startups directory.

How long did the K260456 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Jun 1, 2026, 110 days later.

← All decisions in June 2026

Sources

In the startup directory

Traferox Technologies

Respiratory & Sleep · Mississauga, ON