Cleared Traditional

K013879 - TM2000

K013879 is an FDA 510(k) clearance for TM2000, 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 70-day FDA review.

K013879 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
70d
Days
Class 2
Risk

K013879 is an FDA 510(k) clearance for the TM2000, MODEL 1. 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 February 1, 2002 after a review of 70 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 - K013879

510(k) Number K013879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date February 01, 2002
Days to Decision 70 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 faster than avg
Panel avg: 125d · This submission: 70d
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 K013879.
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K012187 · Card Guard Scientific Survival , Ltd. · Aug 2001