# K991871: Hewlett Packard Multi Function Adult Defib Electrode, Model M3501A & M3502A

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Aug 5, 1999 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
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
The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device for single patient use, only. The M3501A & M3502A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)

Source page: https://510kreport.com/device/K991871
Methodology: https://510kreport.com/methodology