Cleared Traditional

ARBO H79P DISPOSABLE MONITORING ELECTRODES (K894562) - FDA 510(k) Clearance

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

K894562 · Arbo Medical, Inc. · Cardiovascular device
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Sep 1989
Decision
46d
Days
Class 2
Risk

K894562 is an FDA 510(k) clearance for the ARBO H79P DISPOSABLE MONITORING ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Arbo Medical, Inc. (Wilton, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 46 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 Arbo Medical, Inc. devices

Submission Details

510(k) Number K894562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1989
Decision Date September 05, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
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 19
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K894562.
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989
RADIOLUCENT ECG ELECTRODE MODEL NO: 1680
K890201 · Medtronic Vascular · Mar 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989