Company ยท US
Cardiac Science Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2015. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
48recalls (0 in 12 months)
47recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2015 | K143714 | Powerheart G5 AED Cardiac Science Corporation | MKJ |
| Feb 12, 2014 | K122758 | POWERHEART G5 AED Cardiac Science Corporation | MKJ |
| Dec 21, 2011 | K113176 | MYSENSE HEART Cardiac Science Corporation | DSH |
| Jun 9, 2011 | K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS Cardiac Science Corporation | MKJ |
| Jun 3, 2010 | K093211 | CARECENTER MD Cardiac Science Corporation | DPS |
| Sep 10, 2009 | K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A Cardiac Science Corporation | MKJ |
| Dec 12, 2008 | K082090 | 9131 DEFIBRILLATION ELECTRODES Cardiac Science Corporation | MKJ |
| Aug 26, 2008 | K082173 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S Cardiac Science Corporation | DPS |
| May 15, 2006 | K060934 | MODIFICATION TO POWERHEART ECD Cardiac Science Corporation | MKJ |
| Apr 19, 2006 | K060167 | ATRIA 3100, ATRIA 6100 Cardiac Science Corporation | DPS |
| Jan 3, 2006 | K052316 | POWERHEART ECD Cardiac Science, Inc. | MKJ |
| Oct 21, 2005 | K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) Cardiac Science, Inc. | MKJ |
| Aug 6, 2004 | K040637 | POWERHEART AED G3 PRO Cardiac Science, Inc. | MKJ |
| Jul 1, 2004 | K040438 | POWERHEART AED G3A Cardiac Science, Inc. | MKJ |
| Jul 30, 2003 | K031987 | POWERHEART AED G3, MODEL 9300 Cardiac Science | MKJ |
| Jan 27, 2003 | K022929 | PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 Cardiac Science, Inc. | MKJ |
| Oct 4, 2002 | K022210 | MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 Cardiac Science, Inc. | MKJ |
| Nov 16, 2001 | K012197 | POWERHEART CARDIAC RHYTHM MODULE Cardiac Science, Inc. | MKJ |
| Jan 24, 2000 | K993533 | POWERHEART AECD Cardiac Science, Inc. | MKJ |
| Aug 10, 1998 | K982710 | AECD ARRHYTHMIA DETECTION SOFTWARE Cardiac Science, Inc. | MKJ |
| Oct 16, 1997 | K970741 | POWERHEART AECD Cardiac Science, Inc. | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2019 | Cardiac Science Corporation Powerheart G5 Automatic AED Terminated |
MKJ | None listed |
| Mar 9, 2016 | Cardiac Science Corporation 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 Terminated |
MKJ | K102496 |
| Feb 27, 2012 | Cardiac Science Corporation Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Terminated |
MKJ | K031987 K102496 |
| Sep 19, 2011 | Cardiac Science Corporation Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscit Terminated |
MKJ | K031987 K040438 +1 |
| Aug 3, 2011 | Cardiac Science Corporation Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530.
The battery component is warranted for 5 years, and electrodes have a Terminated |
MKJ | K012197 K970741 +2 |
| Dec 10, 2010 | Cardiac Science Corporation GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were manufactured between July 25, 2008 and October 2, 2009 by GE Healthcare. Terminated |
MKJ | K060934 |
| Jun 21, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 |
| Jun 4, 2010 | Cardiac Science Corporation Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science). Terminated |
IOL | K003576 K082173 +2 |
| May 26, 2010 | Cardiac Science Corporation Responder 2000 Defibrillator/Monitor
Models: 2025653, 2026109, and 2026114.
Intended use: The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrill Terminated |
MKJ | K060934 |
| Apr 27, 2010 | Cardiac Science Corporation Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92 Terminated |
MKJ | K031987 |
| Apr 6, 2010 | Cardiac Science Corporation Cardiovive 92532 automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Responder 2023440 automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
B Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9390E automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9390A automated external defibrillator.
This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate).
Brand n Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300P automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300E automated external defibrillator.
This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Br Terminated |
MKJ | K031987 K040438 +3 |
| Apr 6, 2010 | Cardiac Science Corporation Powerheart 9300A automated external defibrillator.
This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate).
Brand na Terminated |
MKJ | K031987 K040438 +3 |
| Mar 4, 2010 | Cardiac Science Corporation NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate).
Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropria Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when ap Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when a Terminated |
MKJ | K031987 K040438 +1 |
| Mar 4, 2010 | Cardiac Science Corporation Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when approp Terminated |
MKJ | K031987 K040438 +1 |
| Feb 25, 2009 | Cardiac Science Corporation GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator Terminated |
MKJ | K052161 |
| Feb 25, 2009 | Cardiac Science Corporation Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated External Defibrillator Terminated |
MKJ | K040438 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390E Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9390A Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300E. Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science First Save Automated External Defibrillator G3 9300C Terminated |
MKJ | K031987 |
| Feb 25, 2009 | Cardiac Science Corporation Cardiac Science Powerheart Automated External Defibrillator G3 9300A Terminated |
MKJ | K031987 |
| Sep 17, 2008 | Cardiac Science Corporation Electrode Adaptor Cable Quick-Combo System, Model 9055
The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibril Terminated |
MKJ | K010214 |
| May 21, 2008 | Cardiac Science Corporation 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021. Terminated |
MKJ | K971149 |
| Mar 2, 2006 | Cardiac Science Corporation Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-79 Terminated |
MKJ | K040438 |
| Jan 15, 2005 | Cardiac Science, Inc. Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN Terminated |
MKJ | K040637 |
| Jan 15, 2005 | Cardiac Science, Inc. Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-79 Terminated |
NPN | K040438 |
| Jan 15, 2005 | Cardiac Science, Inc. Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982. Terminated |
MKJ | K031987 |
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart Automatic External Defibrillator, Model 9210 RD Terminated |
MKJ | K011901 |
| Jul 20, 2004 | Cardiac Science, Inc. FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9143 Terminated |
MKJ | K031987 |
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142 Terminated |
MKJ | K031987 |
| Jul 20, 2004 | Cardiac Science, Inc. Power Heart AED Automatic External Defibrillator, Model 9200 RD Terminated |
MKJ | K011901 |