# K211333: KIDNEY ASSIST-transport

- Pathway: 510(k) (Traditional)
- Applicant: Xvivo Perfusion AB
- Decided: Jan 20, 2022 after 262 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: 1 generation back to K111521 (2012). 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)
- K111521: WAVES, Waters Medical Systems, LLC (2012) Summary page 5.

## Indications for use
The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K211333
Methodology: https://510kreport.com/methodology