Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3D-Side S.A. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221432 | Customize | 3D-Side S.A. | 2022-08-03 | 78 | 0 |
| K213779 | Customize | 3D-Side S.A. | 2022-03-16 | 103 | 0 |
| K212237 | 3D-Cut | 3D-Side S.A. | 2021-11-29 | 133 | 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