# K992977: Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Dec 1, 1999 after 89 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.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has 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
- K081371: Skintact Pediatric Multifunction Electrodes with DH03 Gel (2008), 0 descendants of its own

## Indications for use
The Hewlett Packard External Pediatric electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device for single pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients. When a patient requires defibrillation, cardioversion or extemal pacing, these electrodes will be applied to the pediatric paticnt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.) The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the <+he Hewlett Packard Codemaster Defibrillator.

Source page: https://510kreport.com/device/K992977
Methodology: https://510kreport.com/methodology