# K133694: Sherpa Pak Transporter

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies, Inc.
- Decided: May 23, 2014 after 171 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: 4 generations back to K944866 (1996). 9 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K123326: Sherpa Pak Cardiac Transport System, Paragonix Technologies, Inc. (2013) Summary page 1.
- K091245: Costorsol, Preservation Solutions, Inc. (2009) Summary page 1.
- (no number) Avid Medical Custom Procedure Tray: named in the summary without a submission number

## Most influential descendants
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (2018), 1 descendant of its own
- K261913: X°Port Heart Preservation System (2026), 0 descendants of its own
- K143054: Sherpa Pak Kidney Transport System (2014), 0 descendants of its own

## 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 this organ. The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4 0C and 80C through 24 hours.

Source page: https://510kreport.com/device/K133694
Methodology: https://510kreport.com/methodology