Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitrolife 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) |
|---|---|---|---|---|---|
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022-03-11 | 88 | 0 |
| K182798 | KIDScore D3 | Vitrolife A/S | 2019-07-19 | 290 | 0 |
| K173264 | EmbryoScope+ | Vitrolife A/S | 2018-05-11 | 212 | 0 |
| K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015-12-04 | 238 | 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