FDA applicant

Carefusion Germany 234 GmbH

Hoechberg, DE12 decisions2010–20161 recall

FDA records 12 decisions for Carefusion Germany 234 GmbH (Hoechberg, DE) from 2010 to 2016: 12 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BTY (Calculator, Predicted Values, Pulmonary Function). Its devices cite 25 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Carefusion Germany 234 GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010high 3 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2024

2010high 1 (2024) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Carefusion Germany 234 GmbH by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carefusion Germany 234 GmbH’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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Other applicant names beginning “Carefusion”

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

Carefusion 2200, Inc. 14 Carefusion 303, Inc. 7 Carefusion 209, Inc. 5 Carefusion, Inc. 3 Carefusion (Bd) 1

Carefusion Germany 234 GmbH

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?

What has been recalled?

Other applicant names beginning “Carefusion”