# K991007: K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Aug 23, 1999 after 150 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiclucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This devics is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment: Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett- Packard.

Source page: https://510kreport.com/device/K991007
Methodology: https://510kreport.com/methodology