510(k) Report

FDA applicant

Telemed Div.

Hoffman Estates, IL2 decisions1985–19880 recalls

FDA records 2 decisions for Telemed Div. (Hoffman Estates, IL) from 1985 to 1988: 2 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and DPS (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 Telemed Div.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Telemed Div. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Telemed Div. 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?

  • DRSTransducer, Blood-Pressure, Extravascular1decision
  • DPSElectrocardiograph1decision

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.

  • K880357Omnigraph 6000Telemed Div. · 19881cites it

What has FDA decided for it lately?

  • K880357Omnigraph 6000Telemed Div. · 1988
  • K852652Omnigraph 4000(Electrocardiograph)Telemed Div. · 1985

All 2 as Telemed Div. →

Other applicant names beginning “Telemed”

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

Telemed Systems, Inc. 22Telemed 5Telemed Solutions, Inc. 1