Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paragonix Technologies — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
204 daysmedian FDA review time
306 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | 2024-10-23 | 306 | 1 |
| K223874 | BAROguard | Paragonix Technologies | 2023-08-15 | 235 | 0 |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | 2020-07-02 | 72 | 0 |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies | 2019-12-20 | 204 | 0 |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies | 2018-10-19 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda