# K234060: KIDNEYvault Portable Renal Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Paragonix Technologies
- Decided: Oct 23, 2024 after 306 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
Longest line of descent: 1 generation back to K021362 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Recalls of this device
- Jul 20, 2026 · Class II · Z-2967-2026: Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

## Indications for use
The Paragonix KIDNEYvault Portable Renal Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The Paragonix KIDNEYvault Portable Renal Perfusion System can maintain the donor organ storage temperature between 4°C and 8 ° C through 24 hours Donor kidneys exceeding clinically accepted hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Source page: https://510kreport.com/device/K234060
Methodology: https://510kreport.com/methodology