Cleared Traditional

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE (K020003) - FDA 510(k) Clearance

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

K020003 · Bio Protech, Inc. · Cardiovascular device
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Nov 2002
Decision
309d
Days
Class 2
Risk

K020003 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Sparks, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bio Protech, Inc. devices

Submission Details

510(k) Number K020003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2002
Decision Date November 07, 2002
Days to Decision 309 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
184d slower than avg
Panel avg: 125d · This submission: 309d
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 K020003.
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K901555 · Medtronic Vascular · Jul 1990
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · Medtronic Vascular · Mar 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989