Cleared Traditional

K864293 - HEART TRACK

K864293 is an FDA 510(k) clearance for HEART TRACK, manufactured by Cardio Telemetric Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K864293 · Cardio Telemetric Systems, Inc. · Cardiovascular device
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Mar 1987
Decision
143d
Days
Class 2
Risk

K864293 is an FDA 510(k) clearance for the HEART TRACK. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Cardio Telemetric Systems, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Telemetric Systems, Inc. devices

FDA 510(k) Submission Details - K864293

510(k) Number K864293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date March 23, 1987
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 201
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K864293.
KING OF HEARTS
K880626 · Instromedix, Inc. · Apr 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869 · Labeltape Meditect, Inc. · Nov 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
CMS 8000
K853096 · Physio-Control Corp. · Jan 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985