Cleared Traditional

K943698 - STAT PADZ STERILE ADULT MULTI-FUNCTION ...

K943698 is the FDA 510(k) clearance for STAT PADZ STERILE ADULT MULTI-FUNCTION ... by Zoll Medical Corp. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K943698 · Zoll Medical Corp · Cardiovascular device
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Dec 1994
Decision
152d
Days
Class 3
Risk

K943698 is an FDA 510(k) clearance for the STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 152 days - an extended review 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 Zoll Medical Corp devices

Submission Details

510(k) Number K943698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date December 28, 1994
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 47
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K943698.
PEDIATRIC QUIK-COMBO
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K926172 · Marquette Electronics, Inc. · Feb 1993