Cleared Traditional

K-STIK DEFIBRILLATION PADS (K863899) - FDA 510(k) Clearance

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

K863899 · Katecho, Inc. · Cardiovascular device
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Nov 1986
Decision
36d
Days
Class 2
Risk

K863899 is an FDA 510(k) clearance for the K-STIK DEFIBRILLATION PADS. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 12, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Katecho, Inc. devices

Submission Details

510(k) Number K863899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1986
Decision Date November 12, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 165
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K863899.
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MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
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MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · Hewlett-Packard Co. · Aug 1989
MODEL 43130A DEFIBRILLATOR
K853439 · Hewlett-Packard Co. · Oct 1985