510(k) Report

FDA applicant

<Genx> Intl., Inc.

Madison, CT32 decisions1996–20122 recalls

FDA records 32 decisions for <Genx> Intl., Inc. (Madison, CT) from 1996 to 2012: 32 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQE (Needle, Assisted Reproduction). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Genx Intl., Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided <Genx> Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12009: 12010: 22011: 12012: 1
2007high 2 (2010) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2022

2020: 12022: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — <Genx> Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQLMedia, Reproductive20decisions
  • MQENeedle, Assisted Reproduction3decisions
  • MQGAccessory, Assisted Reproduction3decisions
  • MQKLabware, Assisted Reproduction2decisions
  • MOLCondom, Synthetic1decision
  • MQJMicromanipulators And Microinjectors, Assisted Reproduction1decision

Also: MQF (1), MFD (1).

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993881Genx Culture Dish<Genx> Intl., Inc. · 20002cite it
  • K962816Sperm Preparation MediaGenx Intl., Inc. · 19961cites it
  • K001486Genx Coda Air Purification System<Genx> Intl., Inc. · 20001cites it
  • K070689LG Sperm FreezingGenx Intl., Inc. · 20071cites it
  • K053552Global Fertilization, Embryo Culture and Transfer Media<Genx> Intl., Inc. · 20061cites it
  • K112083Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes<Genx> Intl., Inc. · 20121cites it

What has FDA decided for it lately?

  • K112083Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes<Genx> Intl., Inc. · 2012
  • K092963Global Blastocyst Vitrification Kit & Vitrification Thawing Kit - Based on S3Genx Intl., Inc. · 20111 recall
  • K092667Global Dmso Blastocyst Vitrification Kit and Warming KitGenx Intl., Inc. · 2010
  • K092578Lifeglobal Protein SupplementGenx Intl., Inc. · 2010
  • K083509Lifeglobal Human Serum Albumin LG HsaGenx Intl., Inc. · 2009
  • K080395Sunivf Dishes<Genx> Intl., Inc. · 2008
  • K070689LG Sperm FreezingGenx Intl., Inc. · 2007
  • K053552Global Fertilization, Embryo Culture and Transfer Media<Genx> Intl., Inc. · 2006

All 24 as <Genx> Intl., Inc. →All 8 as Genx Intl., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092963LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055Jun 13, 2022Class II
  • K082508Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/…Aug 18, 2020Class II