Senseonics, Incorporated: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Senseonics, Incorporated” (first 2024, latest 2024), plus 1 PMA and 1 De Novo decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 126 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Senseonics, Incorporated took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SBA | Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | 2 | 1 |
| QCD | Continuous Glucose Monitor, Implanted, Adjunctive Use | 1 | 0 |
Review panels
Most recent Senseonics, Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | SBA | 2024-09-16 | 126 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230052 | De Novo | Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | 2024-04-29 |
| P160048 | PMA | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM | 2018-06-21 |
Recalls
openFDA lists no recalls under a recalling firm named Senseonics, Incorporated.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Senseonics, Incorporated?
FDA lists 1 510(k) clearance under the applicant name “Senseonics, Incorporated” (first 2024, latest 2024), plus 1 PMA and 1 De Novo decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Senseonics, Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Senseonics, Incorporated is 126 days.
Which FDA product codes appear under Senseonics, Incorporated?
The most frequent FDA product codes under this applicant name are SBA (Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate, 2); QCD (Continuous Glucose Monitor, Implanted, Adjunctive Use, 1).
Next steps
- See all 1 Senseonics, Incorporated clearances with predicates and recalls
- Run predicate analysis for product code SBA, Senseonics, Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.