HEARTSINE SAMARITAN PAD 350P— 510(k) K123881

Clearance details

Applicant

Heartsine Technologies, Inc.

Product code

Code MKJ

Device class

Class 3

Regulation

21 CFR 870.5310

Advisory panel

Cardiovascular

Date received

2012-12-17

Decision date

2013-07-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northern, IE

• K143714 — Powerheart G5 AED2015-05-04
• K150055 — OneStep Pediatric CPR Multi-Function Electrode2015-05-02
• K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
• K142709 — samaritan PAD 450P2015-03-27
• K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

• K052465 — REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 3512006-12-12
• K042088 — SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-3012004-09-02
• K041067 — HEARTSINE SAMARITAN PAD2004-05-25
• K023854 — SAMARITAN AED, MODEL SAM-012003-02-14

Death

961

Injury

1,070

Malfunction

90,719

Other

8

Total

92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2115-2014 — 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 designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.Class II·Terminated·Heartsine Technologies, Limited·20140612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123881.