# K243998: DCX Disposable Cassette (DCX)

- Pathway: 510(k) (Traditional)
- Applicant: Institut Geroges Lopez
- Decided: Apr 25, 2025 after 120 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: 2 generations back to K971571 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211224: RM4 Control Unit, Institut Georges Lopez (2021) Summary page 5.

## Indications for use
The DCX Disposable Cassette, as part of the Kidney Perfusion System, is intended to be used for the pulsatile hypothermic machine perfusion (RM4 Kidney Perfusion System) of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.

Source page: https://510kreport.com/device/K243998
Methodology: https://510kreport.com/methodology