# K123326: Sherpa Pak Cardiac Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies, Inc.
- Decided: Feb 6, 2013 after 103 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: 2 generations back to K883782 (1989). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021362: Lifeport, Kidney Perfusion Transporter (KTR), Organ Recovery Systems, Inc. (2003) Summary page 1.
- K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts, Sangstat Medical Corp. (1999) Summary page 1.
- (no number) Avid Custom Procedure Tray: named in the summary without a submission number

## Most influential descendants
- K133694: Sherpa Pak Transporter (2014), 3 descendants of its own
- K133432: Sherpa Pak Cardiac Transport System (2014), 3 descendants of its own
- 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
- K143074: Sherpa Pak Cardiac Transport System (2014), 0 descendants of its own

## Indications for use
The Sherpa Pak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.

Source page: https://510kreport.com/device/K123326
Methodology: https://510kreport.com/methodology