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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 322
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K022909.
SKINTACT
K023920 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT
K024264 · Leonhard Lang Co. · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · Medicotest A/S · Jun 2002
K022909 · NIKOMED TRACE 1 ECG ELECTRODES
Download PDF FDA Summary Nikomed U.S.A., Inc.