Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aevumed, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
317 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 | 63 | 0 |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026-01-28 | 26 | 0 |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 2025-10-21 | 29 | 0 |
| K242895 | Aevumed PHANTOM Suture Anchors | Aevumed, Inc. | 2025-08-06 | 317 | 0 |
| K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | 2023-03-17 | 80 | 0 |
| K222363 | Aevumed PHANTOMâ„¢-LP Suture Anchors | Aevumed, Inc. | 2022-11-28 | 116 | 0 |
| K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | 2018-05-31 | 99 | 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