Cleared Traditional

K-DEFIB/PACE ELECTRODE (K914955) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914955 · Katecho, Inc. · Cardiovascular device
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May 1992
Decision
191d
Days
Class 2
Risk

K914955 is an FDA 510(k) clearance for the K-DEFIB/PACE ELECTRODE. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on May 14, 1992 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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: Standard predicate-based submission. Standard predicate reliance. 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 K914955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date May 14, 1992
Days to Decision 191 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
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 83
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K914955.
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · Hewlett-Packard Co. · May 1995
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757 · Hewlett-Packard Co. · Jul 1992
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · Medtronic Vascular · Jul 1986