Cleared Traditional

K942704 - CARD GUARD

K942704 is an FDA 510(k) clearance for CARD GUARD, 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 180-day FDA review.

K942704 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Dec 1994
Decision
180d
Days
Class 2
Risk

K942704 is an FDA 510(k) clearance for the CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on December 5, 1994 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K942704

510(k) Number K942704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date December 05, 1994
Days to Decision 180 days
Submission Type Traditional
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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 K942704.
HEARTCARD CARDIAC EVENT MONITOR
K944362 · Instromedix, Inc. · Sep 1995
CG-1000 PERSONAL ECG TRANSMITTER
K935909 · Card Guard Scientific Survival , Ltd. · Apr 1995
CARRYALL ENHANCEMENTS
K943931 · Instromedix, Inc. · Apr 1995
PRINCE
K935586 · Instromedix, Inc. · Nov 1994
CARD GUARD, MODEL CG-9000
K924486 · Card Guard Scientific Survival , Ltd. · Oct 1994
CARD GUARD MODEL CG-8000
K926515 · Card Guard Scientific Survival , Ltd. · Mar 1994