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Voluntis

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0478-2019Class IIInsulia Diabetes Management CompanionOctober 8, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250022HeroTracker SenseJune 30, 2025
K232451Insulia Bolus CompanionDecember 12, 2023
K202596Insulia Diabetes Management CompanionJune 4, 2021
K172177Insulia Diabetes Management CompanionNovember 7, 2017
K170669Insulia Diabetes Management CompanionJune 19, 2017
K161433Insulia Diabetes Management CompanionNovember 9, 2016