# K033474: Zoll Aed Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corp
- Decided: May 21, 2004 after 200 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 K003819 (2001). 2 ancestors in all.
72 later devices descend from it; 5 cite it directly.
1 of 75 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022732: Infant/Child Reduced Energy Electrodes, Medtronic Physio-Control Corp. (2002) Summary page 2.

## Most influential descendants
- K042007: Zoll E Series Defibrillator (2005), 64 descendants of its own
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series (2009), 27 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K041892: Zoll Aed Pro External Defibrillator (2005), 23 descendants of its own
- K060559: Zoll R Series Defibrillator (2006), 21 descendants of its own

## Recalls of this device
- Feb 12, 2009 · Not classified · Z-1206-2009: Device fails to discharge the defibrillation energy.

## Indications for use
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 less than 8 years of age, or weighs 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. The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response to defibrillate victims of cardiac arrest.

Source page: https://510kreport.com/device/K033474
Methodology: https://510kreport.com/methodology