# K982710: Aecd Arrhythmia Detection Software

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science, Inc.
- Decided: Aug 10, 1998 after 6 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: 1 generation back to K970741 (1997). 1 ancestor in all.
14 later devices descend from it; 1 cites 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.

## Most influential descendants
- K993533: Powerheart Aecd (2000), 13 descendants of its own
- 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

## 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 AECD Arrhythmia Detection Software, when loaded into 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/K982710
Methodology: https://510kreport.com/methodology