# K960676: Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: Jun 5, 1996 after 106 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- 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
- K040256: Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005 (2004), 0 descendants of its own

## Recalls of this device
- May 28, 2019 · Class II · Z-1945-2019: Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing therapy.

Source page: https://510kreport.com/device/K960676
Methodology: https://510kreport.com/methodology