# K111521: WAVES

- Pathway: 510(k) (Traditional)
- Applicant: Waters Medical Systems, LLC
- Decided: Feb 16, 2012 after 260 days
- Product code: KDN (System, Perfusion, Kidney)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) RM3 Renal Preservation System: named in the summary without a submission number
- (no number) Lifeport Kidney Perfusion Transporter: named in the summary without a submission number

## Most influential descendants
- K211333: KIDNEY ASSIST-transport (2022), 0 descendants of its own

## Recalls of this device
- Mar 21, 2022 · Class II · Z-1013-2022: There is a potential for the WCM cassette pump head leaking solution.

## Indications for use
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K111521
Methodology: https://510kreport.com/methodology