Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Paragonix Technologies, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

65 daysmedian FDA review time
171 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.2026-01-30300
K180194SherpaPak Cardiac Transport System and SherpaPak Kidney TranParagonix Technologies, Inc.2018-03-30650
K143074Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc.2014-11-25290
K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc.2014-11-25330
K133694SHERPA PAK TRANSPORTERParagonix Technologies, Inc.2014-05-231710
K133432SHERPA PAK CARDIAC TRANSPORT SYSTEMParagonix Technologies, Inc.2014-02-211080
K123326SHERPA PAK CARDIAC TRANSPORT SYSTEMParagonix Technologies, Inc.2013-02-061030

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