# K012197: Powerheart Cardiac Rhythm Module

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science, Inc.
- Decided: Nov 16, 2001 after 126 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970741 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993533: Powerheart Aecd, Cardiac Science, Inc. (2000) Summary page 1.

## Recalls of this device
- Jun 29, 2011 · Not classified · Z-2917-2011: Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AE

## Indications for use
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment. Fully Automatic Mode In this mode, the device continuously monitors the patient’s ECG rhythm, detects shockable ventricular tachyarrhythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest. Advisory (AED) Mode In this mode, the device continuously monitors the patient’s ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest. Manual Mode In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy. Pacing The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole.

Source page: https://510kreport.com/device/K012197
Methodology: https://510kreport.com/methodology