Cleared Special

K022297 - GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

K022297 is an FDA 510(k) clearance for GLOBAL ECG MANAGEMENT SYSTEM (GEMS), manufactured by Cardiocomm Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Special 510(k) pathway after a 73-day FDA review.

K022297 · Cardiocomm Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
73d
Days
Class 2
Risk

K022297 is an FDA 510(k) clearance for the GLOBAL ECG MANAGEMENT SYSTEM (GEMS). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardiocomm Solutions, Inc. (Victoria, B.C., CA). The FDA issued a Cleared decision on September 27, 2002 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 - K022297

510(k) Number K022297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date September 27, 2002
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 194
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K022297.
MODIFICATION TO GLOBALCARDIO
K033037 · Cardiocomm Solutions, Inc. · Oct 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · Philips Medical Systems · Jul 2003
CARDIO ID+(RZ153+)
K022540 · Rozinn Electronics, Inc. · Oct 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825 · Card Guard Scientific Survival , Ltd. · Apr 2002
GLOBALCARDIO
K013354 · Cardiocomm Solutions, Inc. · Jan 2002
DR180+OXY
K004007 · North East Monitoring, Inc. · Jan 2001
K022297 · GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
Download PDF FDA Summary Cardiocomm Solutions,…