510(k) Report

FDA applicant

S.C.M.D. Keratomes of Arizona

Ftn. Hills, AZ1 decision1994–19940 recalls

FDA records 1 decision for S.C.M.D. Keratomes of Arizona (Ftn. Hills, AZ) in 1994: 1 510(k) clearance. All are in product code HNO (Keratome, Ac-Powered). 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 S.C.M.D. Keratomes of Arizona’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S.C.M.D. Keratomes of Arizona since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S.C.M.D. Keratomes of Arizona by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HNOKeratome, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K935342SCMD KeratomeS.C.M.D. Keratomes of Arizona · 19942cite it

What has FDA decided for it lately?

  • K935342SCMD KeratomeS.C.M.D. Keratomes of Arizona · 1994

The one decision as S.C.M.D. Keratomes of Arizona →