Cleared Traditional

K882290 - CARD GUARD

K882290 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 51-day FDA review.

K882290 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
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Jul 1988
Decision
51d
Days
Class 2
Risk

K882290 is an FDA 510(k) clearance for the CARD GUARD, MODEL CG-2000. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Israel, IL). The FDA issued a Cleared decision on July 22, 1988 after a review of 51 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 - K882290

510(k) Number K882290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1988
Decision Date July 22, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K882290.
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · Medtronic Vascular · Sep 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
ESCORT - PORTABLE PATIENT MONITOR
K881986 · Medical Data Electronics · Jul 1988
KING OF HEARTS
K880626 · Instromedix, Inc. · Apr 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869 · Labeltape Meditect, Inc. · Nov 1987