Cleared Traditional

K790305 - ELECTRODES

K790305 is the FDA 510(k) clearance for ELECTRODES by Ferris Mfg. Corp.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K790305 · Ferris Mfg. Corp. · Cardiovascular device
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Apr 1979
Decision
49d
Days
Class 2
Risk

K790305 is an FDA 510(k) clearance for the ELECTRODES, FERRIS ECG, TYPES 905,906. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Ferris Mfg. Corp. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 49 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 Ferris Mfg. Corp. devices

Submission Details

510(k) Number K790305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1979
Decision Date April 03, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
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 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K790305.
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
ELECTRODE SYSTEM, QUIK-PREP
K782079 · Quinton, Inc. · Feb 1979
ELECTRODES, OFFSET AND DX
K781963 · Graphic Controls Corp. · Dec 1978
ELECTRODE, DEIP.
K781163 · Datascope Corp. · Sep 1978