Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quibim S.L. · 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) |
|---|---|---|---|---|---|
| K242683 | QP-Prostate® CAD | Quibim S.L. | 2025-03-18 | 193 | 0 |
| K232231 | QP-Brain® | Quibim S.L. | 2023-12-13 | 139 | 0 |
| K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | 2021-02-04 | 59 | 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