FDA applicant

Carefusion, Inc.

Vernon Hills, IL3 decisions2016–20200 recalls

FDA records 3 decisions for Carefusion, Inc. (Vernon Hills, IL) from 2016 to 2020: 3 510(k) clearances. Most are in product codes BZE (Heater, Breathing System W/Wo Controller (Not…) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 241 days from receipt to decision, against 241 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2020

2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Carefusion, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carefusion, 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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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 209, Inc. 5 Carefusion (Bd) 1

Carefusion, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Carefusion”