510(k) Report

FDA applicant

Genosis, Ltd.

Washington, DC2 decisions2003–20040 recalls

FDA records 2 decisions for Genosis, Ltd. (Washington, DC) from 2003 to 2004: 2 510(k) clearances. Most are in product codes POV (Semen Analysis Device) and NGA (Test, Follicle Stimulating Hormone (Fsh), Over…). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

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

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Genosis, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genosis, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genosis, Ltd. 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?

  • POVSemen Analysis Device1decision
  • NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K041039Fertell Male Fertility TestGenosis, Ltd. · 20043cite it
  • K032002Fertell Female Fertility TestGenosis, Inc. · 20031cites it

What has FDA decided for it lately?

  • K041039Fertell Male Fertility TestGenosis, Ltd. · 2004
  • K032002Fertell Female Fertility TestGenosis, Inc. · 2003

The one decision as Genosis, Ltd. →The one decision as Genosis, Inc. →