510(k) Report

FDA applicant

Totemite Medical Electronics

Mchenry, IL2 decisions1981–19870 recalls

FDA records 2 decisions for Totemite Medical Electronics (Mchenry, IL) from 1981 to 1987: 2 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DRW (Adaptor, Lead Switching, Electrocardiograph). 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 Totemite Medical Electronics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Totemite Medical Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Totemite Medical Electronics 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?

  • DSIDetector And Alarm, Arrhythmia1decision
  • DRWAdaptor, Lead Switching, Electrocardiograph1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K872781Easi Lead System Cable AssemblyTotemite Medical Electronics · 19872cite it

What has FDA decided for it lately?

  • K872781Easi Lead System Cable AssemblyTotemite Medical Electronics · 1987
  • K802900Heart SentinelTotemite Medical Electronics · 1981

All 2 as Totemite Medical Electronics →