Paragonix Technologies, Inc.: FDA clearances and approvals
Paragonix Technologies, Inc. has 12 FDA 510(k) clearances (first 2013, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 88 days. Since 2017 its median was 72 days, against 143 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Paragonix Technologies, Inc. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 103 |
| 2014 | 4 | 70 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 43 |
| 2019 | 1 | 204 |
| 2020 | 1 | 72 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 235 |
| 2024 | 1 | 306 |
| 2025 | 0 | — |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, Paragonix Technologies, Inc.'s cleared 510(k)s took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | 7 | 7 |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | 5 | 5 |
Review panels
Most recent Paragonix Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254305 | BAROguard Donor Lung Preservation System | KDN | 2026-01-30 | 30 |
| K234060 | KIDNEYvault Portable Renal Perfusion System | KDN | 2024-10-23 | 306 |
| K223874 | BAROguard | KDN | 2023-08-15 | 235 |
| K201048 | SherpaPak Pediatric Liver Transport System | KDN | 2020-07-02 | 72 |
| K191440 | Paragonix SherpaPak Pancreas Transport System | KDN | 2019-12-20 | 204 |
| K182735 | Paragonix SherpaPak Cardiac Transport System | MSB | 2018-10-19 | 21 |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | MSB | 2018-03-30 | 65 |
| K143074 | Sherpa Pak Cardiac Transport System | MSB | 2014-11-25 | 29 |
| K143054 | Sherpa Pak Kidney Transport System | KDN | 2014-11-25 | 33 |
| K133694 | SHERPA PAK TRANSPORTER | KDN | 2014-05-23 | 171 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-07-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Paragonix Technologies, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT05082077: Global Utilization And Registry Database for Improved preservAtion of doNor Livers (Enrolling by invitation, started 2022-03-15)
- NCT04930289: Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs (Enrolling by invitation, started 2021-10-15)
- NCT04141605: Global Utilization And Registry Database for Improved heArt preservatioN (Enrolling by invitation, started 2020-02-14)
Frequently asked questions
How many FDA 510(k) clearances does Paragonix Technologies, Inc. have?
Paragonix Technologies, Inc. has 12 FDA 510(k) clearances (first 2013, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Paragonix Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Paragonix Technologies, Inc.'s cleared 510(k)s is 88 days. Since 2017: 72 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does Paragonix Technologies, Inc. make?
Its most frequent FDA product codes are KDN (System, Perfusion, Kidney, 7); MSB (System And Accessories, Isolated Heart, Transport And Preservation, 5).
Has Paragonix Technologies, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Paragonix Technologies, Inc; the most recent began 2026-07-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Paragonix Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDN, Paragonix Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.