Cleared Traditional

K964991 - 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

K964991 is an FDA 510(k) clearance for 700-FR SERIES RADIOLUCENT STIMULATION E..., 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 33-day FDA review.

K964991 · Cardiotronics Systems, Inc. · Cardiovascular device
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Jan 1997
Decision
33d
Days
Class 3
Risk

K964991 is an FDA 510(k) clearance for the 700-FR SERIES RADIOLUCENT STIMULATION 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 January 15, 1997 after a review of 33 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 - K964991

510(k) Number K964991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1996
Decision Date January 15, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
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 K964991.
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148 · Cardiotronics Systems, Inc. · May 1997
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
K970719 · Cardiotronics Systems, Inc. · Apr 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · Contour Medical Technology, Inc. · Mar 1997
LIFEPAK 500
K955854 · Physio-Control Corp. · Nov 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
K955882 · Graphic Controls Corp. · Oct 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
K955923 · Graphic Controls Corp. · Oct 1996