# K260456: VI°Port™ Liver Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Traferox Technologies, Inc.
- Decided: Jun 1, 2026 after 110 days
- Product code: KDN (System, Perfusion, Kidney)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K192869 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192869: SherpaPak Lung Preservation System , SherpaPak Liver Transport System, Pragonix Technologies (2020) Summary page 5.

## Indications for use
The VI°Port™ Liver Preservation System is intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the livers. The intended organ storage time for the VI°Port™ Liver Preservation System is up to 15 hours. When clinically accepted static hypothermic preservation times are exceeded, the livers should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Source page: https://510kreport.com/device/K260456
Methodology: https://510kreport.com/methodology