Cleared Traditional

K935909 - CG-1000 PERSONAL ECG TRANSMITTER

K935909 is an FDA 510(k) clearance for CG-1000 PERSONAL ECG TRANSMITTER, 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 505-day FDA review.

K935909 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
505d
Days
Class 2
Risk

K935909 is an FDA 510(k) clearance for the CG-1000 PERSONAL ECG TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on April 28, 1995 after a review of 505 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K935909

510(k) Number K935909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1993
Decision Date April 28, 1995
Days to Decision 505 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
380d slower than avg
Panel avg: 125d · This submission: 505d
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 K935909.
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K944362 · Instromedix, Inc. · Sep 1995
CARRYALL ENHANCEMENTS
K943931 · Instromedix, Inc. · Apr 1995
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704 · Card Guard Scientific Survival , Ltd. · Dec 1994
PRINCE
K935586 · Instromedix, Inc. · Nov 1994