Paragonix Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254305BAROguard Donor Lung Preservation SystemJanuary 30, 2026
K234060KIDNEYvault Portable Renal Perfusion SystemOctober 23, 2024
K223874BAROguardAugust 15, 2023
K201048SherpaPak Pediatric Liver Transport SystemJuly 2, 2020
K191440Paragonix SherpaPak Pancreas Transport SystemDecember 20, 2019
K182735Paragonix SherpaPak Cardiac Transport SystemOctober 19, 2018
K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMarch 30, 2018
K143074Sherpa Pak Cardiac Transport SystemNovember 25, 2014
K143054Sherpa Pak Kidney Transport SystemNovember 25, 2014
K133694SHERPA PAK TRANSPORTERMay 23, 2014
K133432SHERPA PAK CARDIAC TRANSPORT SYSTEMFebruary 21, 2014
K123326SHERPA PAK CARDIAC TRANSPORT SYSTEMFebruary 6, 2013