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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 284
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K072385.
CARDIOSEN'C
K080047 · Shl Telemedicine International , Ltd. · Jul 2008
ECARD AND CCARD
K081471 · iRhythm Technologies, Inc. · Jun 2008
HEARTRAK AF
K071130 · Universal Medical, Inc. · May 2008
FIDELITY 200 CARDIAC EVENT RECORDER
K071228 · Signalife, Inc. · Nov 2007
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
K063609 · Shl Telemedicine International , Ltd. · Sep 2007
SENTINEL
K062397 · Del Mar Reynolds Medical, Ltd. · Jan 2007
K072385 · HEARTEVENT, MODEL AT
Download PDF FDA Summary Diagnostic Devices Pt…