Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Adas3D Medical S.L. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
200 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 | 200 | 0 |
| K240791 | ADAS 3D | Adas3D Medical S.L. | 2024-09-09 | 171 | 0 |
| K230803 | ADAS 3D | Adas3D Medical S.L. | 2023-05-23 | 61 | 0 |
| K212421 | ADAS 3D | Adas3D Medical S.L. | 2021-09-03 | 30 | 0 |
| K210850 | ADAS 3D | Adas3D Medical S.L. | 2021-04-05 | 14 | 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