Cleared Traditional

K833695 - ADULT MONITORING ELECTOR@@RODE 9431-300

K833695 is an FDA 510(k) clearance for ADULT MONITORING ELECTOR@@RODE 9431-300, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K833695 · Marquette Electronics, Inc. · Cardiovascular device
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Jan 1984
Decision
101d
Days
Class 2
Risk

K833695 is an FDA 510(k) clearance for the ADULT MONITORING ELECTOR@@RODE 9431-300. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 101 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K833695

510(k) Number K833695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date January 27, 1984
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 190
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K833695.
CANMED 101
K844100 · Medtronic Vascular · Dec 1984
ESOPHOGRAL MULTIPROBE
K832903 · Vital Signs, Inc. · May 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · Graphic Controls Corp. · Apr 1984
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · Graphic Controls Corp. · Nov 1982
DISPOSABLE ELECTRODE #1900
K822798 · Andover Medical, Inc. · Oct 1982