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HeartSine Technologies Ltd

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
6
Inspections
8
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0288-2026Class IIHeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PADSeptember 18, 2025
Z-2174-2025Class IIHeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (June 30, 2025
Z-1820-2024Class IIHeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PApril 8, 2024
Z-1141-2024Class IIHeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STFebruary 14, 2024
Z-2143-2023Class IIHeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSApril 26, 2023
Z-1217-2023Class IIHeartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillaFebruary 1, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K142709samaritan PAD 450PMarch 27, 2015
K123881HEARTSINE SAMARITAN PAD 350PJuly 11, 2013
K052465REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351December 12, 2006
K042088SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301September 2, 2004
K041067HEARTSINE SAMARITAN PADMay 25, 2004
K023854SAMARITAN AED, MODEL SAM-01February 14, 2003