Cleared Traditional

K864586 - S&W ELECTRODE TYPES 888

K864586 is the FDA 510(k) clearance for S&W ELECTRODE TYPES 888 by S & W Medico Teknik. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K864586 · S & W Medico Teknik · Cardiovascular device
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Mar 1987
Decision
112d
Days
Class 2
Risk

K864586 is an FDA 510(k) clearance for the S&W ELECTRODE TYPES 888, 844, 988 AND 944. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by S & W Medico Teknik (New York, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 112 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 K864586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date March 13, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 K864586.
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986
CANMED 102
K844099 · Medtronic Vascular · Dec 1984