# K121736: Perf-Gen Pulsatile Perfusion Solution

- Pathway: 510(k) (Traditional)
- Applicant: Waters Medical Systems, LLC
- Decided: Aug 16, 2013 after 429 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- 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 K972066 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972066: Belzer-MPS, Trans-Med Corp. (1997) Summary page 1.

## Most influential descendants
- K221386: PERF-GEN Pulsatile Perfusion Solution (2022), 0 descendants of its own
- K211842: Servator M SALF Solution (2021), 0 descendants of its own

## Indications for use
The PER-GEN Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K121736
Methodology: https://510kreport.com/methodology