510(k) Report

FDA applicant

Baxa Infusion Systems

Grass Valley, CA1 decision1995–19950 recalls

FDA records 1 decision for Baxa Infusion Systems (Grass Valley, CA) in 1995: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 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 Baxa Infusion Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baxa Infusion Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Baxa”

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