# K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies, Inc.
- Decided: Mar 30, 2018 after 65 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: 5 generations back to K944866 (1996). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133432: Sherpa Pak Cardiac Transport System, Paragonix Technologies, Inc. (2014) Summary page 4.
- K133694: Sherpa Pak Transporter, Paragonix Technologies, Inc. (2014) Summary page 4.

## Most influential descendants
- K261913: X°Port Heart Preservation System (2026), 0 descendants of its own

## Indications for use
SherpaPak Cardiac Transport System The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times 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. SherpaPak Kidney Transport System The SherpaPak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4̊ C and 8̊ C through 24 hours.

Source page: https://510kreport.com/device/K180194
Methodology: https://510kreport.com/methodology