Cleared Traditional

K950476 - DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM (FDA 510(k) Clearance)

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

K950476 · Nikomed U.S.A., Inc. · Cardiovascular device
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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

Submission Details

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.

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.