Cleared Traditional

K970719 - 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES

K970719 is an FDA 510(k) clearance for 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD..., manufactured by Cardiotronics Systems, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K970719 · Cardiotronics Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
48d
Days
Class 3
Risk

K970719 is an FDA 510(k) clearance for the 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Cardiotronics Systems, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiotronics Systems, Inc. devices

FDA 510(k) Submission Details - K970719

510(k) Number K970719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1997
Decision Date April 16, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 142
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K970719.
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970 · Graphic Controls Corp. · Aug 1997
SVL-9130 DEFIBRILLATION ELECTRODE
K971149 · Survivalink Corp. · Jun 1997
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148 · Cardiotronics Systems, Inc. · May 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · Contour Medical Technology, Inc. · Mar 1997
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
K964991 · Cardiotronics Systems, Inc. · Jan 1997
LIFEPAK 500
K955854 · Physio-Control Corp. · Nov 1996