Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantib B.V. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
159 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253682 | DeepHealth ProstateAI | Quantib B.V. | 2026-04-29 | 159 | 0 |
| K251527 | Brain WMH | Quantib B.V. | 2025-09-25 | 129 | 0 |
| K230772 | Quantib Prostate | Quantib B.V. | 2023-04-17 | 27 | 0 |
| K221106 | Quantib Prostate | Quantib B.V. | 2022-05-13 | 28 | 0 |
| K213737 | Quantib ND | Quantib B.V. | 2022-01-14 | 46 | 0 |
| K202501 | Quantib Prostate | Quantib B.V. | 2020-10-11 | 41 | 0 |
| K200899 | Quantib AI Node | Quantib B.V. | 2020-06-15 | 73 | 0 |
| K182564 | Quantib ND | Quantib B.V. | 2018-12-27 | 100 | 0 |
| K173939 | Quantib Brain | Quantib B.V. | 2018-03-09 | 73 | 0 |
| K163013 | Quantib Brain 1.2 | Quantib B.V. | 2017-01-06 | 70 | 0 |
| K153351 | Quantib Brain 1 | Quantib B.V. | 2016-06-17 | 210 | 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