# K243870: X°Port Lung Preservation System; X°Port Lung Preservation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Traferox Technologies, Inc.
- Decided: May 1, 2025 after 135 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: 5 generations back to K000881 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 6.
- K240650: LungProtect, Traferox Technologies, Inc. (2024) Summary page 6.

## Indications for use
The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution. The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours. When clinically accepted static hypothermic preservation times are exceeded, the lungs 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. The X°Port Lung Preservation Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K243870
Methodology: https://510kreport.com/methodology