Genea Biomedx Pty, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Genea Biomedx Pty, Ltd.” (first 2017, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 190 days. Since 2017 the median was 190 days, against 204 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 4 | 246 |
| 2018 | 2 | 106 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genea Biomedx Pty, Ltd. took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 204 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | 3 | 3 |
| MQL | Media, Reproductive | 3 | 3 |
Review panels
Most recent Genea Biomedx Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | MQG | 2018-06-07 | 135 |
| K180304 | Geri Embryo Incubator and Geri Dish | MQG | 2018-04-20 | 77 |
| K171736 | Geri Embryo Incubator and Geri Dish | MQG | 2017-11-15 | 156 |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | MQL | 2017-09-28 | 223 |
| K162409 | Gems Vitrification Set, Gems Warming Set | MQL | 2017-05-24 | 268 |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | MQL | 2017-05-12 | 373 |
Recalls
openFDA lists no recalls under a recalling firm named Genea Biomedx Pty, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Genea Biomedx Pty, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Genea Biomedx Pty, Ltd.” (first 2017, latest 2018), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genea Biomedx Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genea Biomedx Pty, Ltd. is 190 days. Since 2017: 190 days, versus 204 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genea Biomedx Pty, Ltd.?
The most frequent FDA product codes under this applicant name are MQG (Accessory, Assisted Reproduction, 3); MQL (Media, Reproductive, 3).
Next steps
- See all 6 Genea Biomedx Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQG, Genea Biomedx Pty, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.