# K143054: Sherpa Pak Kidney Transport System

- Pathway: 510(k) (Special)
- Applicant: Paragonix Technologies, Inc.
- Decided: Nov 25, 2014 after 33 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 K944866 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133694: Sherpa Pak Transporter, Paragonix Technologies, Inc. (2014) Summary page 6.
- K944866: Viaspan (Belzer UW - CSS), The Dupont Merck Pharmaceutical Co. (1996) Summary page 6.
- K091245: Costorsol, Preservation Solutions, Inc. (2009) Summary page 6.
- K091656: SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L, Organ Recovery Systems, Inc. (2010) Summary page 6.
- K043461: Custodiol, Dr. Franz Kohler Chemie GmbH (2005) Summary page 6.

## Indications for use
The Sherpa Pak 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 these organs. The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.

Source page: https://510kreport.com/device/K143054
Methodology: https://510kreport.com/methodology