510(k) Report

FDA applicant

Advanced Medical Concepts, Inc.

Brandenton, FL3 decisions1979–19950 recalls

FDA records 3 decisions for Advanced Medical Concepts, Inc. (Brandenton, FL) from 1979 to 1995: 3 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and DTB (Permanent Pacemaker Electrode). 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 Advanced Medical Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Medical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Medical Concepts, 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?

  • BTRTube, Tracheal (W/Wo Connector)1decision
  • DTBPermanent Pacemaker Electrode1decision
  • DPSElectrocardiograph1decision

What has FDA decided for it lately?

  • K951768Teves Ecm Plus ThermocoupleAdvanced Medical Concepts, Inc. · 1995
  • K903671Athans Ekg StandardizerAdvanced Medical Concepts, Inc. · 1991
  • K790983Biflex TM Temporary Pacing ProbeAdvanced Medical Concepts, Inc. · 1979

All 3 as Advanced Medical Concepts, Inc. →