Cleared Traditional

K840646 - CARDIOTRODE

K840646 is an FDA 510(k) clearance for CARDIOTRODE, manufactured by Kholber Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K840646 · Kholber Corp. · Cardiovascular device
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Oct 1984
Decision
254d
Days
Class 2
Risk

K840646 is an FDA 510(k) clearance for the CARDIOTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Kholber Corp. (Miami, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 254 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 Kholber Corp. devices

FDA 510(k) Submission Details - K840646

510(k) Number K840646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1984
Decision Date October 26, 1984
Days to Decision 254 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 197
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K840646.
SYNKARA
K840445 · Lectec Corp. · May 1985
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
ESOPHOGRAL MULTIPROBE
K832903 · Vital Signs, Inc. · May 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · Graphic Controls Corp. · Apr 1984
ADULT MONITORING ELECTOR@@RODE 9431-300
K833695 · Marquette Electronics, Inc. · Jan 1984