# K981802: Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Nov 25, 1998 after 188 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051076: Zoll Stat*Padz MWP Multi-Function Electrodes (2005), 10 descendants of its own
- K110742: Onestep Adult Multi-Function Electrode (2011), 9 descendants of its own
- K120907: Zoll R Series (2012), 6 descendants of its own
- K133269: Zoll X Series (2014), 4 descendants of its own
- K141774: Zoll X Series (2014), 2 descendants of its own

## Indications for use
Modified stat-padz Adult Multi-Function Electrodes will be used for the following clinical applications: Defibritiation Cardioversion Noninvasive Pacing Electrocardiograph Monitoring In conjuction with these devices: ZOLL PD™ 1200 Pacemaker/Defibrillator ZOLL PD™ 1400 Pacemaker/Defibrillator ZOLL PD™ 2000 Pacemaker/Defibrillator ZOLL D 900 Defibrillator ZOLL D 1400 Defibrillator ZOLL D 2000 Defibrillator ZOLL 1600 Pacemaker/Defibrillator ZOLL 1700 Pacemsker/Defibrillator ZOLL NTP 1000 Noninvasive Temporary Pacemaker ZOLL M Series By trained medical personnel, including: Physicians Nurses Paramedics Emergency Medical Technicians (EMT) Cardiovascular Laboratory Technicians In typical settings.

Source page: https://510kreport.com/device/K981802
Methodology: https://510kreport.com/methodology