Cleared Traditional

K964836 - CARD GUARD

K964836 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 241-day FDA review.

K964836 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Jul 1997
Decision
241d
Days
Class 2
Risk

K964836 is an FDA 510(k) clearance for the CARD GUARD, MODEL CG-7100. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Rishon Le Zion, IL). The FDA issued a Cleared decision on July 28, 1997 after a review of 241 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 - K964836

510(k) Number K964836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date July 28, 1997
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
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 K964836.
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · Card Guard Scientific Survival , Ltd. · Dec 1998
CARDIOPAL MODEL NUMBER PM20
K981119 · Medicomp, Inc. · Oct 1998
SENTINEL RECORDER, MODELS 471/472
K971696 · Del Mar Avionics · Dec 1997
CARDIOMAGIC 2000 SOFTWARE
K964036 · Instromedix, Inc. · Jul 1997
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
K963811 · Card Guard Scientific Survival , Ltd. · Dec 1996
CARD GUARD MODEL CG-6500
K954350 · Card Guard Scientific Survival , Ltd. · Sep 1996