510(k) Report

FDA applicant

American Bantex Corp.

Bountiful, UT5 decisions1996–20040 recalls

FDA records 5 decisions for American Bantex Corp. (Bountiful, UT) from 1996 to 2004: 5 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and KGO (Surgeon'S Gloves). Its devices cite 5 predicates, 0 of them its own earlier 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, physical medicine panel, where it files most

How often FDA has decided American Bantex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Bantex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Bantex Corp. 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?

  • INIVehicle, Motorized 3-Wheeled2decisions
  • KGOSurgeon'S Gloves1decision
  • ITIWheelchair, Powered1decision
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K041963American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 PsiAmerican Bantex Corp. · 20041cites it

What has FDA decided for it lately?

  • K042104American Bantex, Model MS 3American Bantex Corp. · 2004
  • K041963American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 PsiAmerican Bantex Corp. · 2004
  • K040754American Bantex MS 4 Mini ScooterAmerican Bantex Corp. · 2004
  • K031711Tango, Models, BP1American Bantex Corp. · 2003
  • K963218Bantex Surgical Latex Gloves- Type 1 Natural Rubber Latex Surgicsl Gloves, SterileAmerican Bantex Corp. · 1996

All 5 as American Bantex Corp. →