Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Voluntis with 6 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jun 30, 2025: HeroTracker Sense.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 30, 2025 | HeroTracker SenseK250022 · CAF | 510(k) clearances |
| Dec 12, 2023 | Insulia Bolus CompanionK232451 · NDC | 510(k) clearances |
| Jun 4, 2021 | Insulia Diabetes Management CompanionK202596 · NDC | 510(k) clearances |
| Oct 8, 2018 | Insulia Diabetes Management CompanionClass II · The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The | Device recalls |
| Nov 7, 2017 | Insulia Diabetes Management CompanionK172177 · NDC | 510(k) clearances |
| Jun 19, 2017 | Insulia Diabetes Management CompanionK170669 · NDC | 510(k) clearances |
| Nov 9, 2016 | Insulia Diabetes Management CompanionK161433 · NDC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
