510(k) Report

FDA applicant

Vermillion

Fremont, CA2 decisions2009–20160 recalls

FDA records 2 decisions for Vermillion (Fremont, CA) from 2009 to 2016: 1 510(k) clearance and 1 De Novo grant. All are in product code ONX (Ovarian Adnexal Mass Assessment Score Test…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Vermillion, 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 Vermillion’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2009: 12016: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Vermillion by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ONXOvarian Adnexal Mass Assessment Score Test System2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

What has FDA decided for it lately?

  • K150588OVA1 Next GenerationVermillion, Inc. · 2016
  • DEN090004OVA1 TestVermillion · 2009

The one decision as Vermillion →The one decision as Vermillion, Inc. →