Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GetingeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Paragonix Technologies with 12 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 20, 2026: Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 20, 2026 | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001Class II · Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank | Device recalls |
| Jan 30, 2026 | BAROguard Donor Lung Preservation SystemK254305 · KDN | 510(k) clearances |
| Oct 23, 2024 | KIDNEYvault Portable Renal Perfusion SystemK234060 · KDN | 510(k) clearances |
| Aug 15, 2023 | BAROguardK223874 · KDN | 510(k) clearances |
| Jul 2, 2020 | SherpaPak Pediatric Liver Transport SystemK201048 · KDN | 510(k) clearances |
| Dec 20, 2019 | Paragonix SherpaPak Pancreas Transport SystemK191440 · KDN | 510(k) clearances |
| Oct 19, 2018 | Paragonix SherpaPak Cardiac Transport SystemK182735 · MSB | 510(k) clearances |
| Mar 30, 2018 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemK180194 · MSB | 510(k) clearances |
| Nov 25, 2014 | Sherpa Pak Cardiac Transport SystemK143074 · MSB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
