# Voluntis Sa.

- Location (FDA's records): Suresnes, FR
- FDA decisions: 6 (2016–2025): 6 510(k) clearances
- Names in FDA's records: Voluntis Sa. (5); Voluntis (1)
- Product codes: NDC (5), CAF (1)
- 510(k) review time since 2016: median 120 days, against 189 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diabetes Care, Inc.: 1 (https://510kreport.com/company/roche-diabetes-care)
- Welldoc, Inc.: 1 (https://510kreport.com/company/welldoc)
- Adherium (Nz), Ltd.: 1 (https://510kreport.com/company/adherium-nz)
- Companion Medical, Inc.: 1 (https://510kreport.com/company/companion-medical)

## Firms that cite its devices most
- Glooko, Inc.: 1 (https://510kreport.com/company/glooko)

## Its most-cited devices
- K161433: Insulia Diabetes Management Companion (2016), cited by 2
- K172177: Insulia Diabetes Management Companion (2017), cited by 1
- K170669: Insulia Diabetes Management Companion (2017), cited by 1

## Recent decisions
- K250022: HeroTracker Sense (Jun 30, 2025)
- K232451: Insulia Bolus Companion (Dec 12, 2023)
- K202596: Insulia Diabetes Management Companion (Jun 4, 2021)
- K172177: Insulia Diabetes Management Companion (Nov 7, 2017)
- K170669: Insulia Diabetes Management Companion (Jun 19, 2017)
- K161433: Insulia Diabetes Management Companion (Nov 9, 2016)

Source page: https://510kreport.com/company/voluntis