510(k) Report

FDA applicant

Medical Profiles, Inc.

Lavonia, MI3 decisions1988–19930 recalls

FDA records 3 decisions for Medical Profiles, Inc. (Lavonia, MI) from 1988 to 1993: 3 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Profiles, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Profiles, 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision
  • DXTInjector And Syringe, Angiographic1decision

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.

  • K914378Peripheral Intervenous CatheterMedical Profiles, Inc. · 19931cites it

What has FDA decided for it lately?

  • K914378Peripheral Intervenous CatheterMedical Profiles, Inc. · 1993
  • K884327Excel Y-Connector Cat. #E-201Medical Profiles, Inc. · 1989
  • K883769Excel Inflate-AidMedical Profiles, Inc. · 1988

All 3 as Medical Profiles, Inc. →