# K012404: K-Defib/Pace Adult Electrode, Model KDP-85

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Oct 12, 2001 after 74 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- 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 electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s 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 device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Source page: https://510kreport.com/device/K012404
Methodology: https://510kreport.com/methodology