Cleared Traditional

K990478 - CARD GUARD

K990478 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 196-day FDA review.

K990478 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Aug 1999
Decision
196d
Days
Class 2
Risk

K990478 is an FDA 510(k) clearance for the CARD GUARD, MODEL CG-6550. 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 August 31, 1999 after a review of 196 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 - K990478

510(k) Number K990478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1999
Decision Date August 31, 1999
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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 K990478.
CG-2100 ECG TRANSMITTER
K994009 · Card Guard Scientific Survival , Ltd. · Dec 1999
CG-7000DX ECG RECORDER/TRANSMITTER
K993799 · Card Guard Scientific Survival , Ltd. · Dec 1999
ECG MINIMONITOR, MODEL CG-5000
K992696 · Card Guard Scientific Survival , Ltd. · Oct 1999
TELEMEDICINE 2000
K992164 · Card Guard Scientific Survival , Ltd. · Aug 1999
TELEMEDICINE 2000
K991307 · Card Guard Scientific Survival , Ltd. · Jun 1999
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · Card Guard Scientific Survival , Ltd. · Dec 1998