Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Velmeni, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 | 216 | 0 |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 | 237 | 0 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 | 174 | 0 |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024-08-30 | 241 | 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