FDA applicant

Graseby Andersen

Smyrna, GA1 decision1997–19970 recalls

FDA records 1 decision for Graseby Andersen (Smyrna, GA) in 1997: 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 Graseby Andersen’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Graseby Andersen since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Graseby Andersen’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 “Graseby”

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

Graseby Medical, Ltd. 5

Graseby Andersen

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Graseby”