# K110526: Zoll Aedpro with 2010 Aha Guidelines Software Update

- Pathway: 510(k) (Special)
- Applicant: ZOLL Medical Corporation
- Decided: Mar 25, 2011 after 29 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003819 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041892: Zoll Aed Pro External Defibrillator, ZOLL Medical Corporation (2005) Summary page 3.

## Indications for use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by * Unconsciousness * Absence of breathing, and * Absence of pulse and other signs of circulation. When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedi-padz II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight. The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.

Source page: https://510kreport.com/device/K110526
Methodology: https://510kreport.com/methodology