Company ยท US
HeartSine Technologies Ltd
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
12recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 18 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2015 | K142709 | samaritan PAD 450P Heartsine Technologies, Inc. | MKJ |
| Jul 11, 2013 | K123881 | HEARTSINE SAMARITAN PAD 350P Heartsine Technologies, Inc., IE | MKJ |
| Dec 12, 2006 | K052465 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 Heartsine Technologies, Inc. | MKJ |
| Sep 2, 2004 | K042088 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 Heartsine Technologies, Inc. | MKJ |
| May 25, 2004 | K041067 | HEARTSINE SAMARITAN PAD Heartsine Technologies, Inc. | MKJ |
| Feb 14, 2003 | K023854 | SAMARITAN AED, MODEL SAM-01 Heartsine Technologies, Inc. | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator);
HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes: 0506016712067
350P US Device, US English (American Airlines) - 2 Min Open, Classified |
MKJ | None listed |
| Sep 4, 2026 | HeartSine Technologies Ltd HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI codes:
0506016712067
350P US Device, US English (American Airlines) - 2 Min CPR
UDI-DI code:
0506016712207
350P US Device, US English Open, Classified |
MKJ | None listed |
| Oct 23, 2025 | HeartSine Technologies Ltd HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J Open, Classified |
MKJ | None listed |
| Jul 25, 2025 | HeartSine Technologies Ltd HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P
The HeartSine samaritan PAD (Public Access Defibrillator) Open, Classified |
MKJ | None listed |
| May 14, 2024 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P Open, Classified |
MKJ | None listed |
| Feb 15, 2024 | HeartSine Technologies Ltd HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-0 Open, Classified |
MKJ | None listed |
| Jul 13, 2023 | HeartSine Technologies Ltd HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P Open, Classified |
MKJ | None listed |
| Mar 3, 2023 | HeartSine Technologies Ltd Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,
SAM 360P fully automatic defibrillator,
SAM 500P semi-automatic defibrillator with CPR Advisor Open, Classified |
MKJ | None listed |
| Jul 24, 2014 | Heartsine Technologies, Limited Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P).
Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically design Terminated |
MKJ | K052465 K123881 |
| Oct 27, 2012 | Heartsine Technologies, Limited HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Product Usage: Samaritan 300/300P PAD is indicated for Terminated |
MKJ | K041067 K052465 |
| Jul 28, 2005 | Heartsine Technologies Inc HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003. Terminated |
MKJ | K023854 |
| Mar 23, 2005 | Heartsine Technologies Inc Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected). Terminated |
MKJ | None listed |