Company ยท US
Paragonix Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2026 | K254305 | BAROguard Donor Lung Preservation System Paragonix Technologies, Inc. | KDN |
| Oct 23, 2024 | K234060 | KIDNEYvault Portable Renal Perfusion System Paragonix Technologies | KDN |
| Aug 15, 2023 | K223874 | BAROguard Paragonix Technologies | KDN |
| Jul 2, 2020 | K201048 | SherpaPak Pediatric Liver Transport System Paragonix Technologies | KDN |
| Dec 20, 2019 | K191440 | Paragonix SherpaPak Pancreas Transport System Paragonix Technologies | KDN |
| Oct 19, 2018 | K182735 | Paragonix SherpaPak Cardiac Transport System Paragonix Technologies | MSB |
| Mar 30, 2018 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System Paragonix Technologies, Inc. | MSB |
| Nov 25, 2014 | K143074 | Sherpa Pak Cardiac Transport System Paragonix Technologies, Inc. | MSB |
| Nov 25, 2014 | K143054 | Sherpa Pak Kidney Transport System Paragonix Technologies, Inc. | KDN |
| May 23, 2014 | K133694 | SHERPA PAK TRANSPORTER Paragonix Technologies, Inc. | KDN |
| Feb 21, 2014 | K133432 | SHERPA PAK CARDIAC TRANSPORT SYSTEM Paragonix Technologies, Inc. | MSB |
| Feb 6, 2013 | K123326 | SHERPA PAK CARDIAC TRANSPORT SYSTEM Paragonix Technologies, Inc. | MSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Paragonix Technologies Inc. Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System
REF# PRGNX-8008-001 Open, Classified |
KDN | K234060 |