# K040256: Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Apr 9, 2004 after 65 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
Longest line of descent: 1 generation back to K915159 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915159: Pediatric Multi-Function Electrodes, Zmi Corp. (1992) Summary page 1.
- K960676: Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004, Zoll Medical Corp (1996) Summary page 1.

## Indications for use
The pediopadzTM Radiolucent MiFE's are intended to be used on pediatric patients, 0-8 years of age at <55 lbs/25kg weight, for defibrillation, non-invasive pacing, cardioversion, and ecg monitoring in conjunction with ZOLL Pacemaker/Defibrillator equipment.

Source page: https://510kreport.com/device/K040256
Methodology: https://510kreport.com/methodology