POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS— 510(k) K102496

Name: FDA 510(k) clearance K102496
Creator: U.S. Food and Drug Administration
Published: 2011-06-09

Substantially Equivalent

Cardiac Science Corporation

FDA 510(k) clearance K102496 for POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS, Substantially Equivalent on 2011-06-09. Applicant: Cardiac Science Corporation. Device class: 3.

Clearance details

Applicant: Cardiac Science Corporation
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2010-08-31
Decision date: 2011-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

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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

More clearances from Cardiac Science Corporation

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K122758 — POWERHEART G5 AED2014-02-12
K113176 — MYSENSE HEART2011-12-21
K093211 — CARECENTER MD2010-06-03
K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A2009-09-10
K082090 — 9131 DEFIBRILLATION ELECTRODES2008-12-12

Adverse events under product code MKJ

product code MKJ

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 →

Recalls naming K102496

K-number listed on FDA's recall record

Z-0829-2016 — 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.Class II·Terminated·Cardiac Science Corporation·20160114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102496.

Data sourced from openFDA. This site is unofficial and independent of the FDA.