# K943698: Stat Padz Sterile Adult Multi-Function Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Dec 28, 1994 after 152 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 16, 2014 · Class II · Z-0052-2015: Product sterility is not assured
- Sep 16, 2014 · Class II · Z-0053-2015: Product sterility is not assured
- Sep 16, 2014 · Class II · Z-0054-2015: Product sterility is not assured
- Sep 16, 2014 · Class II · Z-0055-2015: Product sterility is not assured
- Aug 26, 2014 · Class II · Z-2660-2014: Sterility of device is not assured
- Aug 26, 2014 · Class II · Z-2658-2014: Sterility of device is not assured
- Aug 26, 2014 · Class II · Z-2659-2014: Sterility of device is not assured

Source page: https://510kreport.com/device/K943698
Methodology: https://510kreport.com/methodology