Atlas FDA

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

Prexion Corporation — Predicate Candidate Screening

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

57 daysmedian FDA review time
176 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232166PreXion3D ExpeditionPrexion Corporation2023-09-08490
K222150PreXion3D ExpeditionPrexion Corporation2023-01-121760
K221525PreXion3D Explorer PROPrexion Corporation2022-07-22570
K203784PreXion3D Explorer PROPrexion Corporation2021-02-23570
K193329PreXion3D Explorer EXPrexion Corporation2020-04-091290
K190320PreXion3D ExplorerPrexion Corporation2019-04-15610
K181983PreXion 3D ExcelsiorPrexion Corporation2018-08-17230
K173878PreXion3D ExcelsiorPrexion Corporation2018-01-19290
K161881PreXion3D ExcelsiorPrexion Corporation2016-10-03870

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