Cleared Traditional

K862655 - SIGNA II RESTING ECG ELECTRODE

K862655 is an FDA 510(k) clearance for SIGNA II RESTING ECG ELECTRODE, manufactured by Kone Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K862655 · Kone Instruments, Inc. · Cardiovascular device
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Aug 1986
Decision
23d
Days
Class 2
Risk

K862655 is an FDA 510(k) clearance for the SIGNA II RESTING ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Kone Instruments, Inc. (Milton, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kone Instruments, Inc. devices

FDA 510(k) Submission Details - K862655

510(k) Number K862655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date August 06, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
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 193
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K862655.
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366 · Labeltape Meditect, Inc. · Nov 1986
EM III DISPOSABLE ELECTRODE
K863845 · Electromed Intl., Ltd. · Nov 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · Conmedcorp · Aug 1986
EM DIAGNOSTIC ECG ELECTRODE
K862746 · Electromed Intl., Ltd. · Aug 1986
EUROMED S-601
K862765 · Lectec Corp. · Aug 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433 · Andover Medical, Inc. · May 1986