# P160048: Eversense Continuous Glucose Monitoring System

- Pathway: PMA
- Applicant: Senseonics, Incorporated
- Decided: Jun 21, 2018 after 603 days
- Product code: QCD (Continuous Glucose Monitor, Implanted, Adjunctive Use)
- 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 18, 2019 · Class II · Z-0251-2020: Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

Source page: https://510kreport.com/device/P160048
Methodology: https://510kreport.com/methodology