SBA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1357
- Medical specialty
- Clinical Chemistry
- Flags
- Implant
- FDA definition
- An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.
- Adverse events (MAUDE)
- 2024: 17 · 2025: 1,173 · 2026: 2,024
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Eversense 365 Continuous Glucose Monitoring (CGM) System (K241335) | Senseonics, Incorporated | 2024-09-16 |
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |
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