KDN · Class II · 21 CFR 876.5880

FDA Product Code KDN: System, Perfusion, Kidney

Leading manufacturers include Paragonix Technologies, Inc..

1
Total
1
Cleared
30d
Avg days
2026
Since

FDA 510(k) Cleared System, Perfusion, Kidney Devices (Product Code KDN)

1 devices
1–1 of 1
Cleared Jan 30, 2026
BAROguard Donor Lung Preservation System
K254305
Paragonix Technologies, Inc.
Gastroenterology & Urology · 30d

How to use this database

This page lists all FDA 510(k) submissions for System, Perfusion, Kidney devices (product code KDN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →