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FDA 510(k)

Insulia Diabetes Management Companion

K-Number: K161433 · 2016-11-09

ApplicantVoluntis Sa.
Decision Date2016-11-09
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Insulia Diabetes Management Companion is a medical device manufactured by Voluntis Sa.. It received FDA 510(k) clearance on 2016-11-09 under approval number K161433. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insulia Diabetes Management Companion?

Insulia Diabetes Management Companion is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Voluntis Sa.. The 510(k) number is K161433.

When was Insulia Diabetes Management Companion approved by the FDA?

Insulia Diabetes Management Companion received FDA 510(k) clearance on 2016-11-09, under approval number K161433.

What company makes Insulia Diabetes Management Companion?

Insulia Diabetes Management Companion is manufactured by Voluntis Sa..

What is the FDA product code for Insulia Diabetes Management Companion?

The FDA product code for Insulia Diabetes Management Companion is NDC.

Related Clinical Trials

NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT07372872 Feasibility Testing of the "MyGlucoCare" Smartphone App for Women With Gestational Diabetes RECRUITING NCT06883344 Automated Insulin for Management of Intrapartum Glycemia RECRUITING NCT07589387 Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3 NOT_YET_RECRUITING NCT05447806 Diabetes Clinical Decision Support RECRUITING

Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025) PMID: 40579868 Uric acid to high-density lipoprotein cholesterol ratio is associated with the prevalence of diabetic kidney disease in euthyroid patients with type 1 diabetes mellitus in China: A multicenter cross-sectional study. Journal of diabetes investigation (2025) PMID: 40036206 Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PloS one (2025)

Other Devices by Voluntis Sa.

K172177Insulia Diabetes Management Companion K170669Insulia Diabetes Management Companion K202596Insulia Diabetes Management Companion K232451Insulia Bolus Companion

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa. K160673Insulin Algorithms SystemInsulin Algorithms

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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