Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitrolife AB/Scandinavian Ivf Sciences AB — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
131 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000619 | SCANDINAVIAN IVF SCIENCES AB, G2.2 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-06-27 | 131 | 0 |
| K000627 | SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-06-13 | 117 | 0 |
| K000625 | SCANDINAVIAN IVF SCIENCES AB, G1.2 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-23 | 96 | 0 |
| K000626 | SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-23 | 96 | 0 |
| K000618 | SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-17 | 90 | 0 |
| K000623 | SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-16 | 89 | 0 |
| K000621 | SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100 | Vitrolife AB/Scandinavian Ivf Sciences AB | 2000-05-16 | 89 | 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