510(k) Report

FDA applicant

Hamo USA, Inc.

Miami, FL1 decision1994–19940 recalls

FDA records 1 decision for Hamo USA, Inc. (Miami, FL) in 1994: 1 510(k) clearance. All are in product code MEC (Disinfector, Medical Devices). 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, general hospital panel, where it files most

How often FDA has decided Hamo USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hamo USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hamo USA, Inc. 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?

  • MECDisinfector, Medical Devices1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K911120Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Hamo USA, Inc. · 19941cites it

What has FDA decided for it lately?

  • K911120Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Hamo USA, Inc. · 1994

The one decision as Hamo USA, Inc. →