510(k) Report

FDA applicant

Visgeneer, Inc.

Hsinchu City, TW3 decisions2006–20130 recalls

FDA records 3 decisions for Visgeneer, Inc. (Hsinchu City, TW) from 2006 to 2013: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 3 predicates, 2 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2013

2010: 12013: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Visgeneer, Inc.’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?

  • NBWSystem, Test, Blood Glucose, Over The Counter3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062555Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc. · 20062cite it

What has FDA decided for it lately?

  • K122181Ebchek Blood Glucose Monitoring SystemVisgeneer, Inc. · 2013
  • K091765Ebcarryon Blood Glucose Monitoring SystemVisgeneer, Inc. · 2010
  • K062555Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc. · 2006

All 3 as Visgeneer, Inc. →