# K990106: Zoll First Responder Padz Adult Defibrillation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Feb 26, 1999 after 45 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications: • Defibrillation • Electrocardiograph Monitoring In conjunction 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 Pacemaker/Defibrillator ZOLL NTP 1000 Noninvasive Temporary Pacemaker ZOLL M Series By trained personnel, including: Physicians Nurses Paramedics Emergency Medical Technicians (EMT) Policemen/women Firemen/women In typical settings.

Source page: https://510kreport.com/device/K990106
Methodology: https://510kreport.com/methodology