# K120406: Zoll Fully Automatic Aed Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Medical Corporation, World Wide Headquarters
- Decided: Oct 26, 2012 after 260 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110154: Zoll Aed Plus with 2010 Aha Guidlines Software Update, Zoll Medical Corporation, World Wide Headquarters (2011) Summary page 2.

## Most influential descendants
- K143714: Powerheart G5 AED (2015), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K120406
Methodology: https://510kreport.com/methodology