# K261913: X°Port Heart Preservation System

- Pathway: 510(k) (Traditional)
- Applicant: Traferox Technologies, Inc.
- Decided: Sep 16, 2026 after 100 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- 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: 6 generations back to K944866 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System, Paragonix Technologies, Inc. (2018) Summary page 5.

## Indications for use
The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4–10 °C for up to 4 hours using a del Nido (or equivalent) cold storage solution.

Source page: https://510kreport.com/device/K261913
Methodology: https://510kreport.com/methodology