Cleared Traditional

K023689 - CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM

K023689 is an FDA 510(k) clearance for CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM, manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K023689 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Jan 2003
Decision
77d
Days
Class 2
Risk

K023689 is an FDA 510(k) clearance for the CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM. 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 17, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K023689

510(k) Number K023689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date January 17, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K023689.
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
PMP4 SELFCHECK ECG
K042254 · Card Guard Scientific Survival , Ltd. · Jan 2005
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd. · Feb 2002
TM2000 EASYTRACE PLUS RECEIVING CENTER
K013175 · Card Guard Scientific Survival , Ltd. · Oct 2001