FDA applicant

Kudi Kalu, Inc.

Huntsville, AL1 decision1995–19950 recalls

FDA records 1 decision for Kudi Kalu, Inc. (Huntsville, AL) in 1995: 1 510(k) clearance. All are in product code HKO (Refractometer, Ophthalmic). 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 Kudi Kalu, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kudi Kalu, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kudi Kalu, Inc.

Which product codes does it file in?

What has FDA decided for it lately?