Cleared Traditional

K003228 - K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

K003228 is an FDA 510(k) clearance for K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELE..., manufactured by Katecho, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K003228 · Katecho, Inc. · Cardiovascular device
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Dec 2000
Decision
59d
Days
Class 3
Risk

K003228 is an FDA 510(k) clearance for the K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 59 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 Katecho, Inc. devices

FDA 510(k) Submission Details - K003228

510(k) Number K003228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date December 14, 2000
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 178
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K003228.
ZOLL M SERIES
K010257 · Zoll Medical Corp · Feb 2001
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AEDEFIBRILLATOR
K002232 · Medical Research Laboratories, Inc. · Dec 2000
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K002806 · Katecho, Inc. · Nov 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · Agilent Technologies, Inc. · Sep 2000