# P160030: Freestyle Libre Flash Glucose Monitoring System

- Pathway: PMA
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Sep 27, 2017 after 422 days
- Product code: PZE (Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated)
- Device class: 3
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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 13, 2023 · Class I · Z-1273-2023: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged

Source page: https://510kreport.com/device/P160030
Methodology: https://510kreport.com/methodology