Data / Medical devices / France / Voluntis
Voluntis: FDA-registered device maker in Rueil-Malmaison Hauts-de-Seine, France, 4 510(k) clearances
Voluntis is registered with the FDA (registration 3013530341) in Rueil-Malmaison Hauts-de-Seine, France. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 30, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013530341
- Address
- 12-14 Rue Louis Bleriot, Rueil-Malmaison Hauts-de-Seine, France, 92500
- Owner or operator
- Voluntis (10053592)
- Roles
- Manufacturer
- First device listed
- December 20, 2016
- Registered through
- 2026
- Brand names listed
- HeroTracker Sense, Insulia Diabetes Management Companion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 30, 2025 | K250022 | HeroTracker Sense | CAF | Substantially Equivalent | Voluntis | accessdata.fda.gov |
| November 7, 2017 | K172177 | Insulia Diabetes Management Companion | NDC | Substantially Equivalent | Voluntis Sa. | accessdata.fda.gov |
| June 19, 2017 | K170669 | Insulia Diabetes Management Companion | NDC | Substantially Equivalent | Voluntis Sa. | accessdata.fda.gov |
| November 9, 2016 | K161433 | Insulia Diabetes Management Companion | NDC | Substantially Equivalent | Voluntis Sa. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 8, 2018 | 81508 | Class II | Terminated | Insulia Diabetes Management Companion | The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue. | accessdata.fda.gov |
Compare with other makers
Updated June 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.