Cleared Traditional

K791140 - PREGELLED DISPOSABLE EELCTRO. SERIES 600

K791140 is the FDA 510(k) clearance for PREGELLED DISPOSABLE EELCTRO. SERIES 600 by Hayes Products, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791140 · Hayes Products, Inc. · Cardiovascular device
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Jul 1979
Decision
22d
Days
Class 2
Risk

K791140 is an FDA 510(k) clearance for the PREGELLED DISPOSABLE EELCTRO. SERIES 600. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Hayes Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1979 after a review of 22 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 Hayes Products, Inc. devices

Submission Details

510(k) Number K791140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1979
Decision Date July 10, 1979
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 84
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K791140.
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