Cleared Abbreviated

K071130 - HEARTRAK AF

K071130 is an FDA 510(k) clearance for HEARTRAK AF, manufactured by Universal Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Abbreviated 510(k) pathway after a 387-day FDA review.

K071130 · Universal Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
387d
Days
Class 2
Risk

K071130 is an FDA 510(k) clearance for the HEARTRAK AF. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Universal Medical, Inc. (Ewing, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K071130

510(k) Number K071130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date May 14, 2008
Days to Decision 387 days
Submission Type Abbreviated
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
262d slower than avg
Panel avg: 125d · This submission: 387d
Pathway characteristics
Standards-based clearance path.

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 248
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K071130.
BT3/6, BT12
K082077 · Corscience GmbH & Co. KG · Sep 2008
CARDIOSEN'C
K080047 · Shl Telemedicine International , Ltd. · Jul 2008
ECARD AND CCARD
K081471 · iRhythm Technologies, Inc. · Jun 2008
HEARTEVENT, MODEL AT
K072385 · Diagnostic Devices Pty, Ltd. · Jan 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
K071130 · HEARTRAK AF
Download PDF FDA Summary Universal Medical, In…