# K042088: Samaritan Pad Pak Defibrillation Electrode, Model SPP-301

- Pathway: 510(k) (Traditional)
- Applicant: Heartsine Technologies, Inc.
- Decided: Sep 2, 2004 after 30 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: 2 generations back to K911139 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012414: Prime Ecg System, Meridian Medical Technologies, Inc. (2002) Summary page 1.
- K020715: Philips M5066A and M5068A, Philips Medical Systems (2002) Summary page 1.
- K002806: K-Defib/Pace, Model KDP-60A, Katecho, Inc. (2000) Summary page 1.

## Indications for use
The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, non-sterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Source page: https://510kreport.com/device/K042088
Methodology: https://510kreport.com/methodology