Cleared Traditional

K991007 - K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE

K991007 is the FDA 510(k) clearance for K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE by Katecho, Inc.. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K991007 · Katecho, Inc. · Cardiovascular device
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Aug 1999
Decision
150d
Days
Class 3
Risk

K991007 is an FDA 510(k) clearance for the K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60. 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 August 23, 1999 after a review of 150 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 Katecho, Inc. devices

Submission Details

510(k) Number K991007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1999
Decision Date August 23, 1999
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
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 68
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K991007.
ZOLL M SERIES 12SL ANALYSIS OPTION
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LIFEPAK 12 BIPHASIC
K991910 · Physio-Control Corp. · Sep 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · Hewlett-Packard Co. · Aug 1999
LIFEPAK 500 BIPHASIC
K983393 · Physio-Control Corp. · May 1999
ZOLL M SERIES SPO2 OPTION
K982992 · Zoll Medical Corp · Mar 1999