510(k) Report

FDA applicant

Electromics, Inc.

Walker, MI2 decisions1983–19830 recalls

FDA records 2 decisions for Electromics, Inc. (Walker, MI) in 1983: 2 510(k) clearances. Most are in product codes DTP (Defoamer, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). 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 Electromics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electromics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Electromics, 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?

  • DTPDefoamer, Cardiopulmonary Bypass1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

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.

  • K830728Cardiovascular Disposable ProductsElectromics, Inc. · 19831cites it

What has FDA decided for it lately?

  • K830728Cardiovascular Disposable ProductsElectromics, Inc. · 1983
  • K830727Cardiotomy Reservoir-Filtered & NonElectromics, Inc. · 1983

All 2 as Electromics, Inc. →