Cleared Traditional

SIGNA II RESTING ECG ELECTRODE (K862655) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 23
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K862655.
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
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK
K864868 · Hewlett-Packard Co. · Jan 1987
CANMED 102
K844099 · Medtronic Vascular · Dec 1984
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983