Paragonix Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
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 |
| K143074 | Sherpa Pak Cardiac Transport System | November 25, 2014 |
| K143054 | Sherpa Pak Kidney 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 |