Cleared Traditional

HEARTRAC ECG MONITORING SYSTEM (K934913) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934913 · Cardiac Telecom Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
598d
Days
Class 2
Risk

K934913 is an FDA 510(k) clearance for the HEARTRAC ECG MONITORING SYSTEM. Classified as Hospital Cardiac Telemetry (product code QYW), Class II - Special Controls.

Submitted by Cardiac Telecom Corp. (Washington, D.C., US). The FDA issued a Cleared decision on June 5, 1995 after a review of 598 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cardiac Telecom Corp. devices

Submission Details

510(k) Number K934913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1993
Decision Date June 05, 1995
Days to Decision 598 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
473d slower than avg
Panel avg: 125d · This submission: 598d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QYW Hospital Cardiac Telemetry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
Definition Devices Are Intended To Continuously Record, Display, And/or Analyze Electrocardiograms Of Patients In In A Healthcare Facility For Detecting Conditions That May Require Prompt Intervention. They May Include Automatic Detection And Recording Of Cardiac Electrical Activity, Automated Detection Of Life-threatening Arrhythmias Or Other Relevant Conditions, And/or Alarm Generation. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Devices Are Intended For Patients Who Require Continuous Monitoring In Hospitals Or Healthcare Facilities, With Onsite Medical Review By Qualified Personnel At The Central Monitoring/analysis Station Followed By Immediate Notification Of Onsite Qualified Medical Responders. Devices May Be Used For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. Devices Are Intended For Prescription Use Only.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.