<Genx> Intl., Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “<Genx> Intl., Inc.” (first 1999, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. 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 |
|---|---|---|
| 2012 | 1 | 287 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 15 | 15 |
| MQE | Needle, Assisted Reproduction | 3 | 3 |
| MQG | Accessory, Assisted Reproduction | 2 | 2 |
| MQK | Labware, Assisted Reproduction | 2 | 2 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 1 | 1 |
Review panels
Most recent <Genx> Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | MQL | 2012-05-03 | 287 |
| K080395 | SUNIVF DISHES | MQK | 2008-08-13 | 182 |
| K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | MQL | 2006-05-19 | 150 |
| K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | MQL | 2006-05-09 | 140 |
| K040530 | MEDIA CULTURE SYSTEM | MQL | 2004-06-25 | 116 |
| K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) | MQL | 2002-11-26 | 75 |
| K022590 | PVP (POLYVINYLPYRROLIDONE) | MQL | 2002-08-30 | 25 |
| K022547 | ACIDIFIED TYRODES SOLUTION | MQL | 2002-08-28 | 27 |
| K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) | MQL | 2002-08-28 | 40 |
| K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS | MQL | 2002-08-28 | 41 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named <Genx> Intl., Inc..
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 <Genx> Intl., Inc.?
FDA lists 24 510(k) clearances under the applicant name “<Genx> Intl., Inc.” (first 1999, latest 2012), across 6 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 <Genx> Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name <Genx> Intl., Inc. is 110 days.
Which FDA product codes appear under <Genx> Intl., Inc.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 15); MQE (Needle, Assisted Reproduction, 3); MQG (Accessory, Assisted Reproduction, 2).
Next steps
- See all 24 <Genx> Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQL, <Genx> Intl., Inc.'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.