Paragonix Technologies Inc.
FDA Regulatory Profile
Paragonix Technologies Inc. appears in FDA public data with 1 recall, 12 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2967-2026, Class II) was initiated on July 20, 2026. Its most recent 510(k) clearance was granted on January 30, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2967-2026 | Class II | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 | July 20, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254305 | BAROguard Donor Lung Preservation System | January 30, 2026 |
| K234060 | KIDNEYvault Portable Renal Perfusion System | October 23, 2024 |
| K223874 | BAROguard | August 15, 2023 |
| K201048 | SherpaPak Pediatric Liver Transport System | July 2, 2020 |
| K191440 | Paragonix SherpaPak Pancreas Transport System | December 20, 2019 |
| K182735 | Paragonix SherpaPak Cardiac Transport System | October 19, 2018 |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | March 30, 2018 |
| K143054 | Sherpa Pak Kidney Transport System | November 25, 2014 |
| K143074 | Sherpa Pak Cardiac Transport System | November 25, 2014 |
| K133694 | SHERPA PAK TRANSPORTER | May 23, 2014 |
| K133432 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | February 21, 2014 |
| K123326 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | February 6, 2013 |