510(k) Report

FDA applicant

Cilag GmbH International

Zug, CH3 decisions2011–20131 recall

FDA records 3 decisions for Cilag GmbH International (Zug, CH) from 2011 to 2013: 3 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LFR (Glucose Dehydrogenase, Glucose). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, clinical chemistry panel, where it files most

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

FDA decisions per year

2in 2013

2011: 12013: 2
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2011high 1 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Cilag GmbH International by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions
  • LFRGlucose Dehydrogenase, Glucose1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 20132cite it
  • K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 20111cites it

What has FDA decided for it lately?

  • K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
  • K120708Onetouch Verio Sync Blood Glucose Monitoring SystemCilag GmbH International · 2013
  • K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 20111 recall

All 3 as Cilag GmbH International →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110637OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose…Feb 21, 2012