# P150009: Guardian System

- Pathway: PMA
- Applicant: Avertix Medical, Inc.
- Decided: Apr 9, 2018 after 1,141 days
- Product code: QBI (Acute Coronary Syndrome Event Detector)
- Device class: 3
- 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
- Sep 1, 2023 · Class II · Z-1140-2025: Device reaching End of Service prematurely.

Source page: https://510kreport.com/device/P150009
Methodology: https://510kreport.com/methodology