Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unisense Fertilitech A/S — 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) |
|---|---|---|---|---|---|
| K133712 | EMBRYOVIEWER SOFTWARE | Unisense Fertilitech A/S | 2014-08-08 | 246 | 0 |
| K113075 | EMBRYO VIEWER SOFTWARE | Unisense Fertilitech A/S | 2011-12-21 | 65 | 0 |
| K111715 | EMBRYOSCOPE | Unisense Fertilitech A/S | 2011-08-11 | 52 | 0 |
| K092183 | EMBRYOSCOPE AND EMBRYOSLIDE | Unisense Fertilitech A/S | 2011-01-11 | 539 | 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