510(k) Report

FDA applicant

Heartsine Technologies, Inc.

San Clemente, CA7 decisions2003–201710 recalls

FDA records 7 decisions for Heartsine Technologies, Inc. (San Clemente, CA) from 2003 to 2017: 6 510(k) clearances and 1 original PMA approval. All are in product code MKJ (Automated External Defibrillators (Non-Wearable)). Its devices cite 10 predicates, 4 of them its own earlier devices. 10 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Heartsine Technologies, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Heartsine Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 12015: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2012: 1, 1 Class I2014: 12022: 12023: 22025: 22026 (partial year): 2
2007high 2 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Heartsine Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heartsine Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)7decisions

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 20031cites it
  • K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 20061cites it
  • K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 20041cites it
  • K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 20131cites it

What has FDA decided for it lately?

  • P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P…Heartsine Technologies, Ltd. · 20177 recalls
  • K142709samaritan PAD 450PHeartsine Technologies, Inc. · 2015
  • K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc. · 20131 recall
  • K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 20061 Class I recall
  • K042088Samaritan Pad Pak Defibrillation Electrode, Model SPP-301Heartsine Technologies, Inc. · 2004
  • K041067Heartsine Samaritan PadHeartsine Technologies, Inc. · 20041 Class I recall
  • K023854Samaritan Aed, Model Sam-01Heartsine Technologies, Inc. · 20031 recall

All 6 as Heartsine Technologies, Inc. →The one decision as Heartsine Technologies, Ltd. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • P160008HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US…Jul 27, 2026Class III
  • P160008HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…Jul 27, 2026Class II
  • P160008HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07…Sep 18, 2025Class II
  • P160008HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿…Jun 30, 2025Class II
  • P160008HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with…Apr 26, 2023Class II
  • P160008Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic…Feb 1, 2023Class II