# K123881: Heartsine Samaritan Pad 350P

- Pathway: 510(k) (Traditional)
- Applicant: Heartsine Technologies, Inc.
- Decided: Jul 11, 2013 after 206 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921669 (1993). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041067: Heartsine Samaritan Pad, Heartsine Technologies, Inc. (2004) Summary page 2.
- K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351, Heartsine Technologies, Inc. (2006) Summary page 2.

## Most influential descendants
- 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.

## Indications for use
The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: * Unconscious * Not breathing * Without circulation The samaritan® PAD 350P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The samaritan® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

Source page: https://510kreport.com/device/K123881
Methodology: https://510kreport.com/methodology