# K142709: samaritan PAD 450P

- Pathway: 510(k) (Traditional)
- Applicant: Heartsine Technologies, Inc.
- Decided: Mar 27, 2015 after 186 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: 9 generations back to K921669 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123881: Heartsine Samaritan Pad 350P, Heartsine Technologies, Inc. (2013) Summary page 4.

## Indications for use
The HeartSine samaritan® PAD 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: . Unconscious . Not breathing . Without circulation The samaritan® PAD 450P 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 450P is indicated for use on patients greater than 8 years old or over 55 Ibs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 450P is indicated for use on children between 1 and 8 years of age or up to 55 Ibs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

Source page: https://510kreport.com/device/K142709
Methodology: https://510kreport.com/methodology