510(k) K254305

BAROguard Donor Lung Preservation System by Paragonix Technologies, Inc. — Product Code KDN

K254305 is an FDA 510(k) premarket notification submitted by Paragonix Technologies, Inc. for the device "BAROguard Donor Lung Preservation System". The FDA issued a decision of Substantially Equivalent on January 30, 2026. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Paragonix Technologies, Inc. has at least 10 other 510(k) clearances on record.