Cleared Traditional

QUIK-SILVER RESTING ECG ELECTRODE (K830655) - FDA 510(k) Clearance

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

K830655 · Quinton, Inc. · Cardiovascular device
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Jun 1983
Decision
105d
Days
Class 2
Risk

K830655 is an FDA 510(k) clearance for the QUIK-SILVER RESTING ECG ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 105 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 Quinton, Inc. devices

Submission Details

510(k) Number K830655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1983
Decision Date June 15, 1983
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 22
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K830655.
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 - PREP2 ELECTRODE
K821757 · Quinton, Inc. · Jul 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982
QUINTON LTE ELECTRODE
K810563 · Quinton, Inc. · Mar 1981