# K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351

- Pathway: 510(k) (Traditional)
- Applicant: Heartsine Technologies, Inc.
- Decided: Dec 12, 2006 after 460 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921669 (1993). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052057: Lifepak 500 Automated External Defibrillator, Medtronic Emergency Response Systems, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K123881: Heartsine Samaritan Pad 350P (2013), 1 descendant of its own
- K142709: samaritan PAD 450P (2015), 0 descendants of its own

## Recalls of this device
- Jun 12, 2014 · Class II · Z-2115-2014: A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
- Sep 13, 2012 · Class I · Z-0124-2013: Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off I

## Indications for use
The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

Source page: https://510kreport.com/device/K052465
Methodology: https://510kreport.com/methodology