# K981737: K-Defib/Pace Adult Electrode Model Number KDP-60

- Pathway: 510(k) (Traditional)
- Applicant: Katecho, Inc.
- Decided: Dec 9, 1998 after 205 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.
14 later devices descend from it; 6 cite it directly.
2 of 15 devices 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.

## Most influential descendants
- K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA (2002), 6 descendants of its own
- K020203: Padpro Model #2516 (2002), 5 descendants of its own
- K080421: Heart Sync, Models C-100 and T-100 (2008), 4 descendants of its own
- K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories (2009), 3 descendants of its own
- K131525: Semiautomatic External Defibrillator and Accessories (2014), 0 descendants of its own

## Indications for use
The Katecho “K-Defib/Pace Adult Electrode it is indicated for use in cxternal Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. ‘I'he KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrodc is intended for use on adult patients. When a patient requires defibrillation 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 Joulc maximum), This device has been tested to the ANSI/AAMI DF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

Source page: https://510kreport.com/device/K981737
Methodology: https://510kreport.com/methodology