# K221386: PERF-GEN Pulsatile Perfusion Solution

- Pathway: 510(k) (Traditional)
- Applicant: Institut Georges Lopez
- Decided: Jun 14, 2022 after 32 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: 2 generations back to K972066 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121736: Perf-Gen Pulsatile Perfusion Solution, Waters Medical Systems, LLC (2013) Summary page 4.

## Indications for use
The PERF-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/K221386
Methodology: https://510kreport.com/methodology