510(k) Report

FDA applicant

Stanco Medical, Inc.

Mchenry, IL19 decisions1979–19810 recalls

FDA records 19 decisions for Stanco Medical, Inc. (Mchenry, IL) from 1979 to 1981: 19 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and LDF (Electrode, Pacemaker, Temporary). 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 Stanco Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stanco 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?

  • DYBIntroducer, Catheter5decisions
  • LDFElectrode, Pacemaker, Temporary3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • FPASet, Administration, Intravascular1decision
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • DRIMonitor, Line Isolation1decision

Also: DQY (1), CAZ (1), DYG (1), FMG (1), DTZ (1), DQX (1).

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.

  • K802288Swan Ganz Catheter Placement KitStanco Medical, Inc. · 19801cites it

What has FDA decided for it lately?

  • K810642Atrial-Ventricular Pacing Electrode KitStanco Medical, Inc. · 1981
  • K810643Universal Pacing Electrode KitStanco Medical, Inc. · 1981
  • K802289Pericardiocentesis KitStanco Medical, Inc. · 1980
  • K802287Right Atrial Line KitStanco Medical, Inc. · 1980
  • K802288Swan Ganz Catheter Placement KitStanco Medical, Inc. · 1980
  • K802259Transvenous Pacemaker Electrode KitStanco Medical, Inc. · 1980
  • K802290Regional Intravenous Anesthesia KitStanco Medical, Inc. · 1980
  • K802327Sheath Dilator SetStanco Medical, Inc. · 1980

All 19 as Stanco Medical, Inc. →