# K191440: Paragonix SherpaPak Pancreas Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies
- Decided: Dec 20, 2019 after 204 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 SherpaPakTM Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPakTM Pancreas Transport System can maintain the donor organ storage temperature between 4o C and 8o C up to 21 hours.

Source page: https://510kreport.com/device/K191440
Methodology: https://510kreport.com/methodology