Cleared Special

K042254 - PMP4 SELFCHECK ECG

K042254 is an FDA 510(k) clearance for PMP4 SELFCHECK ECG, manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Special 510(k) pathway after a 146-day FDA review.

K042254 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
146d
Days
Class 2
Risk

K042254 is an FDA 510(k) clearance for the PMP4 SELFCHECK ECG. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on January 13, 2005 after a review of 146 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.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K042254

510(k) Number K042254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2004
Decision Date January 13, 2005
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 115
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K042254.
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911 · Card Guard Scientific Survival , Ltd. · Aug 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556 · Card Guard Scientific Survival , Ltd. · Jan 2006
PMP4 MEDICAL WEB CENTER
K050940 · Card Guard Scientific Survival , Ltd. · Jul 2005
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd. · Feb 2002