# K993745: K-Defib/Pace Adult Electrode, Model KDP-80

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Feb 3, 2000 after 90 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 Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasaive) cardiac pacemakey and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whase output is clasgified as low power (360 Joule maximum). The Katecho KDP-80 Defib/Puce Electrodes are designed for, and to be uged interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.

Source page: https://510kreport.com/device/K993745
Methodology: https://510kreport.com/methodology