# K211224: RM4 Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Institut Georges Lopez
- Decided: Oct 15, 2021 after 175 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 K971571 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971571: RM3 Renal Preservation System--Control Unit, Waters Instruments, Inc. (1997) Summary page 4.

## Most influential descendants
- K243998: DCX Disposable Cassette (DCX) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K211224
Methodology: https://510kreport.com/methodology