510(k) Report

FDA applicant

Cardiac Telecom Corp.

Washington, D.C., DC2 decisions1995–19980 recalls

FDA records 2 decisions for Cardiac Telecom Corp. (Washington, D.C., DC) from 1995 to 1998: 2 510(k) clearances. Most are in product codes QYW (Hospital Cardiac Telemetry) and QYX (Outpatient Cardiac Telemetry). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Cardiac Telecom Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiac Telecom Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiac Telecom Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiac Telecom Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QYWHospital Cardiac Telemetry1decision
  • QYXOutpatient Cardiac Telemetry1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K934913Heartrac Ecg Monitoring SystemCardiac Telecom Corp. · 19951cites it
  • K982803Heartlink, Model IICardiac Telecom Corp. · 19981cites it

What has FDA decided for it lately?

  • K982803Heartlink, Model IICardiac Telecom Corp. · 1998
  • K934913Heartrac Ecg Monitoring SystemCardiac Telecom Corp. · 1995

All 2 as Cardiac Telecom Corp. →