# K041067: Heartsine Samaritan Pad

- Pathway: 510(k) (Special)
- Applicant: Heartsine Technologies, Inc.
- Decided: May 25, 2004 after 32 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003565 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023854: Samaritan Aed, Model Sam-01, Heartsine Technologies, Inc. (2003) Summary page 1.
- K020715: Philips M5066A and M5068A, Philips Medical Systems (2002) Summary page 3.

## 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
- 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 HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs: * Unconscious * Not breathing - Without circulation The Samaritan® PAD 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 is not currently indicated for use on children less than 8 years old.

Source page: https://510kreport.com/device/K041067
Methodology: https://510kreport.com/methodology