VI°Port™ Liver Preservation System

FDA 510(k) K260456 · Traferox Technologies, Inc.

Substantially Equivalent

510(k) numberK260456

Submission

Device name
VI°Port™ Liver Preservation System
Applicant
Traferox Technologies, Inc.
Mississauga, CA
Received
February 11, 2026
Decision date
June 1, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KDN – System, Perfusion, Kidney
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KDN

510(k)DeviceApplicantDecision
K261644Perfadex PlusKDN · Traditional Xvivo Perfusion AB07/23/2026SE
K254305BAROguard Donor Lung Preservation SystemKDN · Special Paragonix Technologies, Inc.01/30/2026SE
K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN · Traditional Bridge TO Life06/17/2025SE
K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional Traferox Technologies, Inc.05/01/2025SE
K243998DCX Disposable Cassette (DCX)KDN · Traditional Institut Geroges Lopez04/25/2025SE
K243384Belzer UW® Cold Storage Solution (BTLBUW-001)KDN · Traditional Bridge TO Life03/31/2025SE
K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN · Traditional Bridge TO Life03/26/2025SE
K240650LungProtectKDN · Traditional Traferox Technologies, Inc.11/26/2024SE
K234060KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional Paragonix Technologies10/23/2024SE
K230193Servator P Plus SALF SolutionKDN · Traditional S.A.L.F. Spa09/21/2023SE

More from S.A.L.F. Spa

510(k)DeviceDecision
K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional 05/01/2025SE
K240650LungProtectKDN · Traditional 11/26/2024SE

Questions and answers

When was VI°Port™ Liver Preservation System cleared by the FDA?

VI°Port™ Liver Preservation System (K260456) received a 510(k) decision of Substantially Equivalent on June 1, 2026, 110 days after the submission was received.

What is the product code of K260456?

The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.