Cleared Traditional

K923558 - ECG ELECTRODE

K923558 is an FDA 510(k) clearance for ECG ELECTRODE, manufactured by Lectec Corp.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K923558 · Lectec Corp. · Cardiovascular device
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Feb 1993
Decision
216d
Days
Class 2
Risk

K923558 is an FDA 510(k) clearance for the ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on February 18, 1993 after a review of 216 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 Lectec Corp. devices

FDA 510(k) Submission Details - K923558

510(k) Number K923558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date February 18, 1993
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 125d · This submission: 216d
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 91
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K923558.
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
TRACET T-6000
K930258 · Lectec Corp. · Apr 1993
MODEL 1300 SOFTRACE II ELECTRODE
K921164 · Medtronic Vascular · Mar 1993
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · Cardiotronics, Inc. · Sep 1991
TRACETS SME 5000
K912450 · Lectec Corp. · Aug 1991
TRACET AG 4000
K904512 · Lectec Corp. · Jan 1991