FDA applicant

Glaxo Australia Ply., Ltd.

Mchenry, IL1 decision1978–19780 recalls

FDA records 1 decision for Glaxo Australia Ply., Ltd. (Mchenry, IL) in 1978: 1 510(k) clearance. All are in product code BZG (Spirometer, Diagnostic). 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 Glaxo Australia Ply., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glaxo Australia Ply., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Glaxo Australia Ply., Ltd.’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 “Glaxo”

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

Glaxo, Inc. 4

Glaxo Australia Ply., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Glaxo”