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K-Defib/Pace Model KDP-60A

by Katecho LLC 510(k)

Active United States

510(k) K002806

Overview

The K-Defib/Pace Model KDP-60A is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It combines defibrillation and pacing capabilities to address both ventricular fibrillation and asystole, providing critical intervention in emergency cardiac situations.

This device is intended for use in pre-hospital and clinical settings by trained personnel, including emergency medical technicians and healthcare providers. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure reliable performance. The K-Defib/Pace Model KDP-60A is classified as a Class III device under FDA regulations (870.5310) and holds a 510(k) clearance for substantial equivalence in the cardiovascular category.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002806 Date21 Nov 2000ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MKJ
FDA applicant
Katecho, Inc.
Device Class
Class III
Regulation
21 CFR Part 870.5310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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