# P160022: X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

- Pathway: PMA
- Applicant: ZOLL Medical Corporation
- Decided: Dec 27, 2017 after 538 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 12, 2019 · Class II · Z-1931-2019: There is a potential for the device to fail to deliver energy to the patient.

Source page: https://510kreport.com/device/P160022
Methodology: https://510kreport.com/methodology