# K993533: Powerheart Aecd

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science, Inc.
- Decided: Jan 24, 2000 after 97 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: 2 generations back to K970741 (1997). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970741: Powerheart Aecd, Cardiac Science, Inc. (1997) Summary page 1.
- K982710: Aecd Arrhythmia Detection Software, Cardiac Science, Inc. (1998) Summary page 2.

## Most influential descendants
- K011901: Firstsave Star Biphasic, Model 9210/9200 (2002), 11 descendants of its own
- K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210 (2003), 10 descendants of its own
- K031987: Powerheart Aed G3, Model 9300 (2003), 8 descendants of its own
- K040438: Powerheart Aed G3A (2004), 6 descendants of its own
- K040637: Powerheart Aed G3 Pro (2004), 3 descendants of its own

## 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 AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

Source page: https://510kreport.com/device/K993533
Methodology: https://510kreport.com/methodology