510(k) Report

FDA applicant

Medical Technologies International, Inc.

Flint Mi, MI3 decisions1985–20050 recalls

FDA records 3 decisions for Medical Technologies International, Inc. (Flint Mi, MI) from 1985 to 2005: 3 510(k) clearances. Most are in product codes LIF (Dialyzer Reprocessing System) and LYY (Latex Patient Examination Glove). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Medical Technologies International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Technologies International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Technologies International, 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?

  • LIFDialyzer Reprocessing System1decision
  • LYYLatex Patient Examination Glove1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K050376ProwinMedical Technologies International, Inc. · 20051cites it

What has FDA decided for it lately?

  • K050376ProwinMedical Technologies International, Inc. · 2005
  • K935131Family First Aid KitMedical Technologies International, Inc. · 1994
  • K850799Rinse Machine KR-4 Kidney Rinse-4Medical Technologies International, Inc. · 1985

All 3 as Medical Technologies International, Inc. →