510(k) Report

FDA applicant

Fertipro NV

Irvine, CA4 decisions2006–20250 recalls

FDA records 4 decisions for Fertipro NV (Irvine, CA) from 2006 to 2025: 4 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and QBD (Microbial Nucleic Acid Storage And…). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Fertipro NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12024: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fertipro NV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fertipro NV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQLMedia, Reproductive3decisions
  • QBDMicrobial Nucleic Acid Storage And Stabilization Device1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K053494Oil for Tissue Culture, Gradient System and SpermfreezeFertipro NV · 20061cites it
  • K070135Vitrifreeze Medium; Vitrithaw MediumFertipro NV · 20071cites it

What has FDA decided for it lately?

  • K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV · 2025
  • K221547InActiv BlueFertipro NV · 2024
  • K070135Vitrifreeze Medium; Vitrithaw MediumFertipro NV · 2007
  • K053494Oil for Tissue Culture, Gradient System and SpermfreezeFertipro NV · 2006

All 4 as Fertipro NV →