# K241335: Eversense 365 Continuous Glucose Monitoring (CGM) System

- Pathway: 510(k) (Traditional)
- Applicant: Senseonics, Incorporated
- Decided: Sep 16, 2024 after 126 days
- Product code: SBA (Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate)
- Device class: 2
- Regulation: 21 CFR 862.1357
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230052 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230052: Eversense AP CGM System, Senseonics, Incorporated (2024) Summary page 7.

## Indications for use
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to: • Provide real-time glucose readings. • Provide glucose trend information. • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time. The Eversense 365 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense 365 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. The system is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K241335
Methodology: https://510kreport.com/methodology