Cleared Traditional

K020003 - ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

K020003 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH (ECG) ELECTRODE, manufactured by Bio Protech, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K020003 · Bio Protech, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K020003

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
Combination Product No
PCCP Authorized No
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.

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 324
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K020003.
SKINTACT
K024264 · Leonhard Lang Co. · Jan 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · Nikomed U.S.A., Inc. · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · Medicotest A/S · Jun 2002
NEOLEAD
K011564 · Neotech Products, Inc. · Jan 2002
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
K003804 · Niko Medical Products · Aug 2001
K020003 · ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
Download PDF FDA Summary Bio Protech, Inc.