# K053169: RM3 Renal Preservation System

- Pathway: 510(k) (Special)
- Applicant: Waters Instruments, Inc.
- Decided: Jan 17, 2006 after 64 days
- Product code: KDK (Container, Transport, 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.
No later device cites it as a predicate yet.
0 of 1 device 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) RM3 Renal Preservation System: named in the summary without a submission number

## Indications for use
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.

Source page: https://510kreport.com/device/K053169
Methodology: https://510kreport.com/methodology