Cleared Traditional

K072385 - HEARTEVENT, MODEL AT

K072385 is an FDA 510(k) clearance for HEARTEVENT, manufactured by Diagnostic Devices Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K072385 · Diagnostic Devices Pty, Ltd. · Cardiovascular device
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Jan 2008
Decision
140d
Days
Class 2
Risk

K072385 is an FDA 510(k) clearance for the HEARTEVENT, MODEL AT. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Diagnostic Devices Pty, Ltd. (Eastgardens, AU). The FDA issued a Cleared decision on January 11, 2008 after a review of 140 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 Diagnostic Devices Pty, Ltd. devices

FDA 510(k) Submission Details - K072385

510(k) Number K072385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2007
Decision Date January 11, 2008
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 143
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