Voluntis Sa.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Voluntis Sa.” (first 2016, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 116 days, against 130 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 169 |
| 2017 | 2 | 108 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 269 |
| 2022 | 0 | — |
| 2023 | 1 | 120 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Voluntis Sa. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NDC | Calculator, Drug Dose | 5 | 5 |
Review panels
Most recent Voluntis Sa. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232451 | Insulia Bolus Companion | NDC | 2023-12-12 | 120 |
| K202596 | Insulia Diabetes Management Companion | NDC | 2021-06-04 | 269 |
| K172177 | Insulia Diabetes Management Companion | NDC | 2017-11-07 | 111 |
| K170669 | Insulia Diabetes Management Companion | NDC | 2017-06-19 | 105 |
| K161433 | Insulia Diabetes Management Companion | NDC | 2016-11-09 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Voluntis Sa..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Voluntis (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Voluntis Sa.?
FDA lists 5 510(k) clearances under the applicant name “Voluntis Sa.” (first 2016, latest 2023), across 1 product code 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 Voluntis Sa.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Voluntis Sa. is 120 days. Since 2017: 116 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Voluntis Sa.?
The most frequent FDA product codes under this applicant name are NDC (Calculator, Drug Dose, 5).
Next steps
- See all 5 Voluntis Sa. clearances with predicates and recalls
- Run predicate analysis for product code NDC, Voluntis Sa.'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.