<Genx> Intl., Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under 2 spellings of the applicant name “<Genx> Intl., Inc.” (first 1996, latest 2012), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 122 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 | 20 | 20 |
| MQE | Needle, Assisted Reproduction | 3 | 3 |
| MQG | Accessory, Assisted Reproduction | 3 | 3 |
| MQK | Labware, Assisted Reproduction | 2 | 2 |
| MFD | Cannula, Intrauterine Insemination | 1 | 1 |
| MOL | Condom, Synthetic | 1 | 1 |
| 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 |
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | MQL | 2011-01-14 | 476 |
| K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | MQL | 2010-06-03 | 276 |
| K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | MQL | 2010-04-05 | 227 |
| K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | MQL | 2009-04-24 | 149 |
| K080395 | SUNIVF DISHES | MQK | 2008-08-13 | 182 |
| K070689 | LG SPERM FREEZING | MQL | 2007-07-03 | 112 |
| 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 |
22 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- <Genx> Intl., Inc. (24)
- Genx Intl., Inc. (8)
Frequently asked questions
How many FDA 510(k) clearances are listed under <Genx> Intl., Inc.?
FDA lists 32 510(k) clearances under 2 spellings of the applicant name “<Genx> Intl., Inc.” (first 1996, latest 2012), across 8 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 122 days.
Which FDA product codes appear under <Genx> Intl., Inc.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 20); MQE (Needle, Assisted Reproduction, 3); MQG (Accessory, Assisted Reproduction, 3).
Next steps
- See all 32 <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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.