FDA applicant

Lifescan Europe

Zug, CH3 decisions2015–20200 recalls

FDA records 3 decisions for Lifescan Europe (Zug, CH) from 2015 to 2020: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Lifescan Europe GmbH”.

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 Lifescan Europe’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Lifescan Europe by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Lifescan”

FDA records each applicant name separately; these may or may not be the same firm.

Lifescan, Inc. 42 Lifescan Europe, A Division of Cilag GmbH 1

Lifescan Europe

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lifescan”