FDA applicant

Carefusion 209, Inc.

Middleton, WI5 decisions2011–20121 recall

FDA records 5 decisions for Carefusion 209, Inc. (Middleton, WI) from 2011 to 2012: 5 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and IKT (Electrode, Needle, Diagnostic Electromyograph). Its devices cite 19 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, neurology panel, where it files most

How often FDA has decided Carefusion 209, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2011high 3 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Carefusion 209, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carefusion 209, Inc.’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 “Carefusion”

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

Carefusion 2200, Inc. 14 Carefusion Germany 234 GmbH 12 Carefusion 303, Inc. 7 Carefusion, Inc. 3 Carefusion (Bd) 1

Carefusion 209, Inc.

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”