# K100565: Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Nov 16, 2010 after 260 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K150198: CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K100565
Methodology: https://510kreport.com/methodology