# K971571: RM3 Renal Preservation System--Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Waters Instruments, Inc.
- Decided: Jul 29, 1997 after 90 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) MOX-100 Renal Preservation System TM2 Transport Module: named in the summary without a submission number

## Most influential descendants
- K211224: RM4 Control Unit (2021), 1 descendant of its own
- K243998: DCX Disposable Cassette (DCX) (2025), 0 descendants of its own

## Indications for use
The Waters Medical Systems (Waters Instruments, Inc.) RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.

Source page: https://510kreport.com/device/K971571
Methodology: https://510kreport.com/methodology