Cleared Traditional

K812878 - THE NEW 1600 ELECTRODE

K812878 is the FDA 510(k) clearance for THE NEW 1600 ELECTRODE by Andover Medical, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K812878 · Andover Medical, Inc. · Cardiovascular device
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Nov 1981
Decision
19d
Days
Class 2
Risk

K812878 is an FDA 510(k) clearance for the THE NEW 1600 ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Walker, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 19 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 Andover Medical, Inc. devices

Submission Details

510(k) Number K812878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1981
Decision Date November 02, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
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 45
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K812878.
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
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
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979
ECG ELECTRODES, PEDIATRIC-FOAM TAPE
K791002 · Physio-Control Corp. · Jun 1979