Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genea Biomedx Pty, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
223 daysmedian FDA review time
373 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Soft | Genea Biomedx Pty, Ltd. | 2018-06-07 | 135 | 0 |
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2018-04-20 | 77 | 0 |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017-11-15 | 156 | 0 |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | Genea Biomedx Pty, Ltd. | 2017-09-28 | 223 | 0 |
| K162409 | Gems Vitrification Set, Gems Warming Set | Genea Biomedx Pty, Ltd. | 2017-05-24 | 268 | 0 |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage M | Genea Biomedx Pty, Ltd. | 2017-05-12 | 373 | 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