Cleared Traditional

K864586 - S&W ELECTRODE TYPES 888, 844, 988 AND 944

K864586 is an FDA 510(k) clearance for S&W ELECTRODE TYPES 888, manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K864586

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
Combination Product No
PCCP Authorized No
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.

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 147
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K864586.
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871 · Labeltape Meditect, Inc. · Oct 1987
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · Lectec Corp. · Apr 1987
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
K865011 · Labeltape Meditect, Inc. · Mar 1987
TRACETS 2000/ELECTRODES
K863674 · Lectec Corp. · Mar 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · Graphic Controls Corp. · Feb 1987