FDA applicant

Australian Optical Co., Inc.

Kansas City, MO8 decisions1991–19940 recalls

FDA records 8 decisions for Australian Optical Co., Inc. (Kansas City, MO) from 1991 to 1994: 8 510(k) clearances. Most are in product codes HQZ (Frame, Spectacle) and HQY (Sunglasses (Non-Prescription Including…). 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, ophthalmic panel, where it files most

How often FDA has decided Australian Optical Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Australian Optical Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Australian Optical Co., 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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Other applicant names beginning “Australian”

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

Australian Biomedical Corporation, Ltd. 5 Australian Surgical Design & Manufacture 1 Australian Surgical Devices 1

Australian Optical Co., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Australian”