Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Therapixel — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260714 | MammoScreen® (5) | Therapixel | 2026-06-26 | 113 | 0 |
| K243685 | MammoScreen BD | Therapixel | 2025-08-22 | 266 | 0 |
| K243679 | MammoScreen® (4) | Therapixel | 2025-07-03 | 216 | 0 |
| K241561 | MammoScreen BD | Therapixel | 2024-10-02 | 124 | 0 |
| K240301 | MammoScreen® (3) | Therapixel | 2024-08-01 | 182 | 0 |
| K211541 | MammoScreen 2.0 | Therapixel | 2021-11-26 | 191 | 0 |
| K192854 | MammoScreen | Therapixel | 2020-03-25 | 173 | 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