Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atrium Medical Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
476 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | 2024-03-28 | 269 | 0 |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest | Atrium Medical Corporation | 2021-09-03 | 476 | 4 |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR Centr | Atrium Medical Corporation | 2015-10-22 | 149 | 0 |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | Atrium Medical Corporation | 2015-08-27 | 90 | 1 |
| K130142 | FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corporation | 2013-03-15 | 52 | 0 |
| K110110 | ATRIUM CENTRILFX MESH | Atrium Medical Corporation | 2011-02-15 | 32 | 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