Cleared Traditional

K950476 - DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM

K950476 is an FDA 510(k) clearance for DISPOSABLE ECG MONITORING ELECTRODE #44..., manufactured by Nikomed U.S.A., Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K950476 · Nikomed U.S.A., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
215d
Days
Class 2
Risk

K950476 is an FDA 510(k) clearance for the DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Nikomed U.S.A., Inc. (Doylestown, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 215 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 Nikomed U.S.A., Inc. devices

FDA 510(k) Submission Details - K950476

510(k) Number K950476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date September 06, 1995
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
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 176
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K950476.
CONMED ECG/EKG ELECTRODES
K954389 · Conmedcorp · May 1996
CONMED EKG STRIPPER
K960264 · Conmedcorp · Apr 1996
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
K950488 · Graphic Controls Corp. · Jul 1995