# Senseonics, Incorporated

- Location (FDA's records): Germantown, MD
- FDA decisions: 3 (2018–2024): 1 510(k) clearance, 1 De Novo grant and 1 original PMA approval
- Product codes: SBA (2), QCD (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN230052: Eversense AP CGM System (2024), cited by 1

## Recent decisions
- K241335: Eversense 365 Continuous Glucose Monitoring (CGM) System (Sep 16, 2024)
- DEN230052: Eversense AP CGM System (Apr 29, 2024)
- P160048: Eversense Continuous Glucose Monitoring System (Jun 21, 2018)

Source page: https://510kreport.com/company/senseonics