Cleared Traditional

K884983 - M55 K KARAYA GUM DISP. MICROTAPE ECG EL...

K884983 is the FDA 510(k) clearance for M55 K KARAYA GUM DISP. MICROTAPE ECG EL... by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K884983 · S & W Medico Teknik · Cardiovascular device
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Mar 1989
Decision
100d
Days
Class 2
Risk

K884983 is an FDA 510(k) clearance for the M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55. 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 March 9, 1989 after a review of 100 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. 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 K884983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1988
Decision Date March 09, 1989
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 K884983.
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
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988