# K023854: Samaritan Aed, Model Sam-01

- Pathway: 510(k) (Traditional)
- Applicant: Heartsine Technologies, Inc.
- Decided: Feb 14, 2003 after 87 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: 1 generation back to K003565 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003565: Heartstream FR2 Aed, Model M3860A,M3861A, Agilent Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K041067: Heartsine Samaritan Pad (2004), 2 descendants of its own
- 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
- Oct 5, 2005 · Not classified · Z-1046-05: Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.

## Indications for use
The Heartsine Samaritan@AEDis indicated for use on victims of cardiac arrest who are exhibiting the following signs: Unconscious Not breathing Without circulation The Samaritan@AEDis intended for use by personnel who have been trained in its operation. Users should have received training in basic life support I AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan@AED is not currently indicated for use on children less than 8 years old.

Source page: https://510kreport.com/device/K023854
Methodology: https://510kreport.com/methodology