# Heartsine Technologies, Inc.

- Location (FDA's records): San Clemente, CA
- FDA decisions: 7 (2003–2017): 6 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Heartsine Technologies, Inc. (6); Heartsine Technologies, Ltd. (1)
- Product codes: MKJ (7)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)
- Meridian Medical Technologies, Inc.: 1 (https://510kreport.com/company/meridian-medical-technologies)
- Katecho, Inc.: 1 (https://510kreport.com/company/katecho)
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)
- Medtronic Emergency Response Systems, Inc.: 1 (https://510kreport.com/company/medtronic-emergency-response-systems)

## Its most-cited devices
- K023854: Samaritan Aed, Model Sam-01 (2003), cited by 1
- K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351 (2006), cited by 1
- K041067: Heartsine Samaritan Pad (2004), cited by 1
- K123881: Heartsine Samaritan Pad 350P (2013), cited by 1

## Recent decisions
- P160008: HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (Jan 12, 2017)
- K142709: samaritan PAD 450P (Mar 27, 2015)
- K123881: Heartsine Samaritan Pad 350P (Jul 11, 2013)
- K052465: Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351 (Dec 12, 2006)
- K042088: Samaritan Pad Pak Defibrillation Electrode, Model SPP-301 (Sep 2, 2004)
- K041067: Heartsine Samaritan Pad (May 25, 2004)
- K023854: Samaritan Aed, Model Sam-01 (Feb 14, 2003)

Source page: https://510kreport.com/company/heartsine-technologies