FDA applicant

Carefusion (Bd)

San Diego, CA1 decision2025–20250 recalls

FDA records 1 decision for Carefusion (Bd) (San Diego, CA) in 2025: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 1 predicate, 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Carefusion (Bd) by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carefusion (Bd)’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 209, Inc. 5 Carefusion, Inc. 3

Carefusion (Bd)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Carefusion”