Chrysalis Intelligence · Sponsors · Senseonics, Incorporated

Senseonics, Incorporated

Germantown, MD, US · 2 510(k) clearances · 14 PMAs

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Total clearances
2
2024-04-29 → 2024-09-16
Last 12 months
0
Product codes
1
Most recent
2024-09-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate Class II Clinical Chemistry 2 2024-09-16
Class III

PMA approvals (14)

Total PMA records
14
Originals + supplements
Distinct product codes
2
First decision
2020-12-11
Most recent
2026-03-19
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-03-19 P160048-S031 Eversense® Continuous Glucose Monitoring System Normal 180 Day Track No User Fee QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown
2025-03-27 P160048-S029 EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Normal 180 Day Track No User Fee QHJ — —
2024-10-23 P160048-S028 Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans 30-Day Notice QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown
2024-02-22 P160048-S027 Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert 30-Day Notice QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown
2023-12-05 P160048-S026 Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert Normal 180 Day Track No User Fee QCD Continuous Glucose Monitor, Implanted, Adjunctive Use Unknown
2023-06-09 P160048-S025 Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert 30-Day Notice QHJ — —
2023-05-10 P160048-S024 Eversense E3 CGM System 30-Day Notice QHJ — —
2023-03-30 P160048-S022 Eversense® E3 Continuous Glucose Monitoring (CGM) System Normal 180 Day Track QHJ — —
2023-03-29 P160048-S021 Eversense® E3 Continuous Glucose Monitoring (CGM) System Panel Track QHJ — —
2023-03-22 P160048-S023 Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert Normal 180 Day Track No User Fee QHJ — —
2022-05-24 P160048-S019 Eversense E3 Continuous Glucose Monitoring System Normal 180 Day Track No User Fee QHJ — —
2022-05-04 P160048-S018 Eversense E3 Continuous Glucose Monitoring System Normal 180 Day Track No User Fee QHJ — —
2022-02-10 P160048-S016 Eversense® E3 Continuous Glucose Monitoring System Panel Track QHJ — —
2020-12-11 P160048-S017 Eversense Continuous Glucose Monitoring System 30-Day Notice QHJ — —
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2024-09-16 K241335 Eversense 365 Continuous Glucose Monitoring (CGM) System SBA Class II Clinical Chemistry
2024-04-29 DEN230052 Eversense AP CGM System SBA Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence