510(k) Report

FDA applicant

Cardiac Science Corporation

Bothell, WA21 decisions1997–201543 recalls

FDA records 21 decisions for Cardiac Science Corporation (Bothell, WA) from 1997 to 2015: 21 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and DPS (Electrocardiograph). Its devices cite 40 predicates, 18 of them its own earlier devices. 43 recalls are linked to its devices.

FDA’s records also spell it “Cardiac Science, Inc.”, “Cardiac Science”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiac Science Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 22009: 12010: 12011: 22014: 12015: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2008: 72009: 182010: 82011: 22012: 12016: 1
2007high 18 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiac Science Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiac Science Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MKJAutomated External Defibrillators (Non-Wearable)17decisions
  • DPSElectrocardiograph3decisions
  • DSHRecorder, Magnetic Tape, Medical1decision

Whose devices does it build on?

Its devices cite 40 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 18 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031987Powerheart Aed G3, Model 9300Cardiac Science · 20036cite it
  • K040438Powerheart Aed G3ACardiac Science, Inc. · 20044cite it
  • K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210Cardiac Science, Inc. · 20034cite it
  • K0820909131 Defibrillation ElectrodesCardiac Science Corporation · 20083cite it
  • K060167Atria 3100, Atria 6100Cardiac Science Corporation · 20063cite it
  • K993533Powerheart AecdCardiac Science, Inc. · 20002cite it

What has FDA decided for it lately?

  • K143714Powerheart G5 AEDCardiac Science Corporation · 2015
  • K122758Powerheart G5 AedCardiac Science Corporation · 2014
  • K113176Mysense HeartCardiac Science Corporation · 2011
  • K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 PlusCardiac Science Corporation · 20112 recalls
  • K093211Carecenter MDCardiac Science Corporation · 2010
  • K091943Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390ACardiac Science Corporation · 20097 recalls
  • K0820909131 Defibrillation ElectrodesCardiac Science Corporation · 2008
  • K082173Q-Stress and Heartstride, Models Qstress/Q40 and H4/H4SCardiac Science Corporation · 20081 recall

All 10 as Cardiac Science Corporation →All 10 as Cardiac Science, Inc. →The one decision as Cardiac Science →

What has been recalled?

43 recalls linked to its devices; the latest:

  • K1024969131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A…Jan 14, 2016Class II
  • K031987Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following…Jan 13, 2012
  • K031987Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency…Jun 30, 2011
  • K012197Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN…Jun 29, 2011
  • K060934GE Responder 2000 Defibrillator/Monitor, models 2025653, 2026109, and 2026114 that were…Apr 28, 2010
  • K031987Responder 2023440 automated external defibrillator. This semi-automatic model requires…Feb 3, 2010