# K041892: Zoll Aed Pro External Defibrillator

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Feb 4, 2005 after 206 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: 3 generations back to K003819 (2001). 5 ancestors in all.
23 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011541: Zoll Pad with CPR Aid, Zoll Medical Corp (2002) Summary page 1.
- K033474: Zoll Aed Plus, Zoll Medical Corp (2004) Summary page 1.
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) Summary page 1.

## Most influential descendants
- K060559: Zoll R Series Defibrillator (2006), 21 descendants of its own
- K100654: Zoll Propaq MD (2010), 11 descendants of its own
- K110742: Onestep Adult Multi-Function Electrode (2011), 9 descendants of its own
- K102468: Zoll Propaq MD (2010), 9 descendants of its own
- K112432: Zoll X Series (2012), 8 descendants of its own

## 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, and * Absence of normal breathing, and * Absence of a pulse or signs of circulation. When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should be used with ZOLL pedi-padz II defibrillation electrodes. Therapy should not be delayed to determine the patient's exact age or weight. At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable to provide a non-diagnostic display of a breathing or responsive patient's ECG rhythm, regardless of their age. While connected to the AED Pro ECG Cable, the AED Pro performs a background analysis the patient's rhythm and disables its defibrillator feature. Contraindications for Use - Defibrillation Do not use the AED Pro unit for defibrillation when the patient * Is conscious; or * Is breathing; or * Has a detectable pulse or other signs of circulation. Contraindications for Use - CPR Monitoring The CPR monitoring function is not intended for use on patients under 8 years of age.

Source page: https://510kreport.com/device/K041892
Methodology: https://510kreport.com/methodology