510(k) Report

FDA applicant

Baxterhealthcare, Inc.

Deerfield Lake, IL1 decision2007–200719 recalls

FDA records 1 decision for Baxterhealthcare, Inc. (Deerfield Lake, IL) in 2007: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 19 recalls are 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 Baxterhealthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

6in 2011

2007: 42009: 32010: 62011: 6
2007high 6 (2010) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Baxterhealthcare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baxterhealthcare, 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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