Cleared Special

K073625 - MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

K073625 is an FDA 510(k) clearance for MODIFICATION TO: MAC 5500 RESTING ECG A..., manufactured by Ge Healthcare Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 30-day FDA review.

K073625 · Ge Healthcare Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
30d
Days
Class 2
Risk

K073625 is an FDA 510(k) clearance for the MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Healthcare Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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. Low regulatory complexity profile. 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 - K073625

510(k) Number K073625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date January 25, 2008
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 577
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K073625.
HERO, VERSION 2.0
K081473 · Medical Predictive Science Corp. · Jun 2008
PAGEWRITER CARDIOGRAPH
K080999 · Philips Medical Systems · May 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · Medtechs, LLC · Apr 2008
PORTABLE ECSCOPE 12I
K080036 · Dyansys, Inc. · Jan 2008
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · Welch Allyn, Inc. · Nov 2007
THE PORTABLE ANSISCOPE
K071168 · Dyansys, Inc. · Aug 2007
K073625 · MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
Download PDF FDA Summary Ge Healthcare Systems…