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Defib K-Pads

by Katecho LLC 510(k)

Active United States

510(k) K895662

Overview

Defib K-Pads is a low-energy defibrillator device that includes paddles, classified as a Class II cardiovascular device under product code LDD. It received FDA 510(k) clearance as substantially equivalent through the traditional pathway on January 18, 1990, under K895662.

The device is manufactured by Katecho, Inc. and is intended for use in cardiovascular applications. It is supplied as a non-sterile, disposable device for single patient use only, with no indication of reusability, sterility, MRI safety, or specific sizes provided in the data.

AI-generated from registry data, 28 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 NumberK895662 Date18 Jan 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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
LDD
FDA applicant
Katecho, Inc.
Device Class
Class II
Regulation
21 CFR Part 870.5300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Katecho LLC

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Questions

  • What is the DEFIB K-PADS device used for?

    The DEFIB K-PADS is a low-energy defibrillator device that includes paddles and is intended for use in cardiovascular applications, as stated in the device description.

  • Is the DEFIB K-PADS device sterile or non-sterile, and is it reusable?

    The DEFIB K-PADS is supplied as a non-sterile, disposable device for single patient use only, with no indication of reusability provided in the data.

  • What regulatory pathway was used for the DEFIB K-PADS device clearance?

    The DEFIB K-PADS received FDA 510(k) clearance as substantially equivalent through the traditional pathway on January 18, 1990, under K895662.