FDA applicant

Baxa Corp.

Englewood, CO8 decisions1994–201015 recalls

FDA records 8 decisions for Baxa Corp. (Englewood, CO) from 1994 to 2010: 8 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FRN (Pump, Infusion). Its devices cite 4 predicates, 2 of them its own earlier devices. 15 recalls are linked to its devices, 6 Class I.

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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Baxa Corp.’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 “Baxa”

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

Baxa Corp., Sub. of Cook Group, Inc. 16 Baxa Infusion Systems 1

Baxa Corp.

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 “Baxa”