# K021362: Lifeport, Kidney Perfusion Transporter (KTR)

- Pathway: 510(k) (Traditional)
- Applicant: Organ Recovery Systems, Inc.
- Decided: Jul 31, 2003 after 457 days
- Product code: KDN (System, Perfusion, Kidney)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123326: Sherpa Pak Cardiac Transport System (2013), 6 descendants of its own
- K133694: Sherpa Pak Transporter (2014), 3 descendants of its own
- K133432: Sherpa Pak Cardiac Transport System (2014), 3 descendants of its own
- K203262: Cannula for Organ Perfusion (2021), 1 descendant of its own
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (2018), 1 descendant of its own

## Recalls of this device
- Jan 30, 2020 · Class II · Z-1437-2020: Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

## Indications for use
LifePortTM, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K021362
Methodology: https://510kreport.com/methodology