# P180028: HeartStart FRx Defibrillator

- Pathway: PMA
- Applicant: Philips Medical Systems
- Decided: May 11, 2020 after 647 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
- Feb 9, 2021 · Class II · Z-0079-2022: Customers were not notified of previous recalls associated with various defibrillator models.

Source page: https://510kreport.com/device/P180028
Methodology: https://510kreport.com/methodology