510(k) Report

FDA applicant

Trac Medical, Inc.

Raliegh, NC2 decisions1993–19940 recalls

FDA records 2 decisions for Trac Medical, Inc. (Raliegh, NC) from 1993 to 1994: 2 510(k) clearances. Most are in product codes IQA (System, Environmental Control, Powered) and OXO (Image-Intensified Fluoroscopic X-Ray System…). 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 Trac Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Trac Medical, 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?

  • IQASystem, Environmental Control, Powered1decision
  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile1decision

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.

  • K933431Orthotrac Coaxial LaserTrac Medical, Inc. · 19931cites it

What has FDA decided for it lately?

  • K944345Bedside ButlerTrac Medical, Inc. · 1994
  • K933431Orthotrac Coaxial LaserTrac Medical, Inc. · 1993

All 2 as Trac Medical, Inc. →

Other applicant names beginning “Trac”

FDA records each applicant name separately; these may or may not be the same firm.

Trac About, Inc. 1