Cleared Traditional

QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (K090496) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090496 · Cardiac Lead Technologies, Inc. · Cardiovascular device
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Sep 2009
Decision
188d
Days
Class 2
Risk

K090496 is an FDA 510(k) clearance for the QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cardiac Lead Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 188 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 Cardiac Lead Technologies, Inc. devices

Submission Details

510(k) Number K090496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date September 01, 2009
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K090496.
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RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
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K891075 · C.R. Bard, Inc. · Mar 1989