510(k) Report

FDA applicant

Vysis

Downers Grove, IL9 decisions1996–20041 recall

FDA records 9 decisions for Vysis (Downers Grove, IL) from 1996 to 2004: 8 510(k) clearances and 1 De Novo grant. Most are in product codes OYU (Dna-Probe Kit, Human Chromosome) and MMW (System, Test, Tumor Marker, Monitoring, Bladder). 1 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Vysis since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vysis 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?

  • OYUDna-Probe Kit, Human Chromosome3decisions
  • MMWSystem, Test, Tumor Marker, Monitoring, Bladder3decisions
  • NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ…1decision
  • OXPDna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment1decision
  • OVQChronic Lymphocytic Leukemia Fish Probe Kit1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • DEN040010Vysis Autovysion SystemVysis · 20043cite it
  • K013785Urovysion Bladder Cancer Recurrence KitVysis · 20021cites it
  • K011031Vysis Urovysion Bladder Cancer Recurrence KitVysis · 20011cites it
  • K033982Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 20041cites it

What has FDA decided for it lately?

  • DEN040010Vysis Autovysion SystemVysis · 2004
  • K033982Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 2004
  • K013785Urovysion Bladder Cancer Recurrence KitVysis · 20021 recall
  • K011031Vysis Urovysion Bladder Cancer Recurrence KitVysis · 20011 recall
  • K010288Aneuvysion Muliticolor Dna Probe KitVysis · 2001
  • K972200AneuvysionVysis · 1997
  • K954214Cep X Spectrumorange\Y Spectrumgreen Dna Probe KitVysis · 1997
  • K962873Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna ProbeVysis · 1997

All 9 as Vysis →

What has been recalled?

1 recall linked to its devices; the latest:

  • K013785ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH)…Feb 19, 2004