Cleared Special

K022909 - NIKOMED TRACE 1 ECG ELECTRODES

K022909 is an FDA 510(k) clearance for NIKOMED TRACE 1 ECG ELECTRODES, manufactured by Nikomed U.S.A., Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 128-day FDA review.

K022909 · Nikomed U.S.A., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
128d
Days
Class 2
Risk

K022909 is an FDA 510(k) clearance for the NIKOMED TRACE 1 ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Nikomed U.S.A., Inc. (Stillwater, US). The FDA issued a Cleared decision on January 9, 2003 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nikomed U.S.A., Inc. devices

FDA 510(k) Submission Details - K022909

510(k) Number K022909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date January 09, 2003
Days to Decision 128 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Modification to existing cleared device.

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 176
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K022909.
SKINTACT ECG TAB ELECTRODE
K030509 · Leonhard Lang GmbH · Mar 2003
SKINTACT
K023920 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000