# K201048: SherpaPak Pediatric Liver Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies
- Decided: Jul 2, 2020 after 72 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Paragonix SherpaPak™ Pediatric Liver Transport System is intended to be used for the static hypothermic preservation of pediatric donor livers or partial adult livers intended for pediatric recipients 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 Paragonix SherpaPak™ Pediatric Liver Transport System is up to 15 hours. Donor livers 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.

Source page: https://510kreport.com/device/K201048
Methodology: https://510kreport.com/methodology