Cleared Traditional

K932028 - PD-1400 PACER/DEFIBRILLATOR

K932028 is the FDA 510(k) clearance for PD-1400 PACER/DEFIBRILLATOR by Zoll Medical Corp. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K932028 · Zoll Medical Corp · Cardiovascular device
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Oct 1993
Decision
165d
Days
Class 3
Risk

K932028 is an FDA 510(k) clearance for the PD-1400 PACER/DEFIBRILLATOR. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Zoll Medical Corp (Woburn, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 165 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 K932028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1993
Decision Date October 08, 1993
Days to Decision 165 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
40d slower than avg
Panel avg: 125d · This submission: 165d
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 K932028.
MARQUETTE DEFIB ELECTRODE
K941262 · Marquette Electronics, Inc. · Apr 1995
FAST-PATCH
K941970 · Physio-Control Corp. · Dec 1994
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR
K925936 · Physio-Control Corp. · Jun 1994
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K926172 · Marquette Electronics, Inc. · Feb 1993
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K892005 · Physio-Control Corp. · Jun 1989
LIFEPAK 250 DEFIBRILLATOR/MONITOR
K892065 · Physio-Control Corp. · Jun 1989