Cleared Traditional

K884980 - F56 K KARAYA GUM DISP. PE-FOAM ECG ELEC...

K884980 is the FDA 510(k) clearance for F56 K KARAYA GUM DISP. PE-FOAM ECG ELEC... by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K884980 · S & W Medico Teknik · Cardiovascular device
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May 1989
Decision
153d
Days
Class 2
Risk

K884980 is an FDA 510(k) clearance for the F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on May 1, 1989 after a review of 153 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 S & W Medico Teknik devices

Submission Details

510(k) Number K884980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date May 01, 1989
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 125d · This submission: 153d
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.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 45
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K884980.
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BABY MAC ELECTROCARDIOGRAPH ELECTRODE
K895834 · Marquette Electronics, Inc. · Nov 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · Medtronic Vascular · Mar 1989
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262 · Valleylab, Inc. · Jan 1989