Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Screenpoint Medical B.V. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
153 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024-11-25 | 153 | 0 |
| K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | 2023-12-11 | 151 | 0 |
| K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022-08-03 | 86 | 0 |
| K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021-06-02 | 112 | 0 |
| K193229 | Transpara | Screenpoint Medical B.V. | 2020-03-05 | 104 | 0 |
| K192287 | Transpara | Screenpoint Medical B.V. | 2019-12-10 | 110 | 0 |
| K181704 | Transpara | Screenpoint Medical B.V. | 2018-11-21 | 147 | 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