# K091561: Zoll Aed Plus Version 5.32 Software Release

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Sep 23, 2010 after 483 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). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033474: Zoll Aed Plus, Zoll Medical Corp (2004) Summary page 2.

## Indications for use
The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: * Unconsciousness and * Absence of normal breathing and * Absence of a pulse or signs of circulation When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Source page: https://510kreport.com/device/K091561
Methodology: https://510kreport.com/methodology