# K960329: Disposable Hydrogel Defibrillation Electrode/Pad

- Pathway: 510(k) (Traditional)
- Applicant: Contour Medical Technology, Inc.
- Decided: Jul 2, 1996 after 160 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022210: Multifunctional Electrode Models 9640, 9650 (2002), 0 descendants of its own

## Recalls of this device
- Aug 19, 2015 · Class II · Z-2547-2015: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clini

Source page: https://510kreport.com/device/K960329
Methodology: https://510kreport.com/methodology