Voluntis
FDA Regulatory Profile
Voluntis appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0478-2019, Class II) was initiated on October 8, 2018. Its most recent 510(k) clearance was granted on June 30, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0478-2019 | Class II | Insulia Diabetes Management Companion | October 8, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250022 | HeroTracker Sense | June 30, 2025 |
| K232451 | Insulia Bolus Companion | December 12, 2023 |
| K202596 | Insulia Diabetes Management Companion | June 4, 2021 |
| K172177 | Insulia Diabetes Management Companion | November 7, 2017 |
| K170669 | Insulia Diabetes Management Companion | June 19, 2017 |
| K161433 | Insulia Diabetes Management Companion | November 9, 2016 |