Cleared Special

K033451 - HEARTRAK SMART AT/HEARTRAK SMART2

K033451 is an FDA 510(k) clearance for HEARTRAK SMART AT/HEARTRAK SMART2, manufactured by Universal Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Special 510(k) pathway after a 98-day FDA review.

K033451 · Universal Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
98d
Days
Class 2
Risk

K033451 is an FDA 510(k) clearance for the HEARTRAK SMART AT/HEARTRAK SMART2. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Universal Medical, Inc. (Philadelphia, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 98 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033451

510(k) Number K033451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date February 05, 2004
Days to Decision 98 days
Submission Type Special
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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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
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K033451 · HEARTRAK SMART AT/HEARTRAK SMART2
Download PDF FDA Summary Universal Medical, In…