Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wandercraft SAS — 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) |
|---|---|---|---|---|---|
| K260381 | Eve | Wandercraft SAS | 2026-08-03 | 179 | 0 |
| K250904 | Atalante X | Wandercraft SAS | 2025-10-24 | 212 | 0 |
| K232077 | Atalante X | Wandercraft SAS | 2023-12-13 | 153 | 0 |
| K221859 | Atalante | Wandercraft SAS | 2022-12-29 | 185 | 1 |
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