Cleared Traditional

K926175 - K-DEFIB/PACE CARBON ELECTRODE

K926175 is the FDA 510(k) clearance for K-DEFIB/PACE CARBON ELECTRODE by Katecho, Inc.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K926175 · Katecho, Inc. · Cardiovascular device
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Apr 1993
Decision
128d
Days
Class 2
Risk

K926175 is an FDA 510(k) clearance for the K-DEFIB/PACE CARBON 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 April 15, 1993 after a review of 128 days - within the typical 510(k) review window.

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 K926175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date April 15, 1993
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 20
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K926175.
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
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LIFEPAK 11
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K950483 · Hewlett-Packard Co. · May 1995
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS
K915757 · Hewlett-Packard Co. · Jul 1992
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · Physio-Control Corp. · Sep 1991
NKA MODEL SEC-3102 CARDIAC STIMULATOR
K894492 · Nihon Kohden America, Inc. · Dec 1989