510(k) Report

FDA applicant

Senseonics, Incorporated

Germantown, MD3 decisions2018–20241 recall

FDA records 3 decisions for Senseonics, Incorporated (Germantown, MD) from 2018 to 2024: 1 510(k) clearance, 1 De Novo grant and 1 original PMA approval. Most are in product codes SBA (Integrated Continuous Glucose Monitoring…) and QCD (Continuous Glucose Monitor, Implanted…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Senseonics, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2018: 12024: 2
2018high 2 (2024) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2018high 1 (2019) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Senseonics, Incorporated by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone…2decisions
  • QCDContinuous Glucose Monitor, Implanted, Adjunctive Use1decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN230052Eversense AP CGM SystemSenseonics, Incorporated · 20241cites it

What has FDA decided for it lately?

  • K241335Eversense 365 Continuous Glucose Monitoring (CGM) SystemSenseonics, Incorporated · 2024
  • DEN230052Eversense AP CGM SystemSenseonics, Incorporated · 2024
  • P160048Eversense Continuous Glucose Monitoring SystemSenseonics, Incorporated · 20181 recall

All 3 as Senseonics, Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • P160048Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose MonitorSep 18, 2019Class II