Cleared Traditional

K791006 - SMART BILECTRODES

K791006 is an FDA 510(k) clearance for SMART BILECTRODES, manufactured by Electronics For Medicine, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K791006 · Electronics For Medicine, Inc. · Cardiovascular device
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Jun 1979
Decision
11d
Days
Class 2
Risk

K791006 is an FDA 510(k) clearance for the SMART BILECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Electronics For Medicine, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1979 after a review of 11 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 Electronics For Medicine, Inc. devices

FDA 510(k) Submission Details - K791006

510(k) Number K791006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1979
Decision Date June 11, 1979
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
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 197
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K791006.
INFANT ECG ELECTRODE #60-1029
K810102 · Aspen Laboratories, Inc. · Jan 1981
ADULT ECG ELECTRODE #60-0724
K810103 · Aspen Laboratories, Inc. · Jan 1981
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979
ECG ELECTRODES, PEDIATRIC-FOAM TAPE
K791002 · Physio-Control Corp. · Jun 1979
ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA
K791003 · Physio-Control Corp. · Jun 1979
LIFEPATCH ECG ELECTRODES
K790959 · Physio-Control Corp. · May 1979