# P160028: Philips HeartStart FR3 Defibrillator

- Pathway: PMA
- Applicant: Philips Medical Systems, Inc.
- Decided: May 11, 2020 after 1,382 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
- Oct 10, 2018 · Class II · Z-0175-2019: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

Source page: https://510kreport.com/device/P160028
Methodology: https://510kreport.com/methodology