# K150198: CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: May 2, 2015 after 93 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
Longest line of descent: 9 generations back to K962603 (1997). 28 ancestors in all.
No later device cites it as a predicate yet.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100565: Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325, Bio-Detek, Inc. (2010) Summary page 4.
- K110742: Onestep Adult Multi-Function Electrode, ZOLL Medical Corporation (2011) Summary page 4.

## Indications for use
Defibrillation ECG Monitoring Cardioversion CPR Feedback The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules: AED Pro M Series E Series R Series The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians First Responders The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators. The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Source page: https://510kreport.com/device/K150198
Methodology: https://510kreport.com/methodology