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FDA 510(k)

Glooko Mobile Insulin Dosing System

K-Number: K171450 · 2018-02-02

ApplicantGlooko, Inc.
Decision Date2018-02-02
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Glooko Mobile Insulin Dosing System is a medical device manufactured by Glooko, Inc.. It received FDA 510(k) clearance on 2018-02-02 under approval number K171450. 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 Glooko Mobile Insulin Dosing System?

Glooko Mobile Insulin Dosing System is a medical device that received FDA 510(k) clearance on 2018-02-02. It is manufactured by Glooko, Inc.. The 510(k) number is K171450.

When was Glooko Mobile Insulin Dosing System approved by the FDA?

Glooko Mobile Insulin Dosing System received FDA 510(k) clearance on 2018-02-02, under approval number K171450.

What company makes Glooko Mobile Insulin Dosing System?

Glooko Mobile Insulin Dosing System is manufactured by Glooko, Inc..

What is the FDA product code for Glooko Mobile Insulin Dosing System?

The FDA product code for Glooko Mobile Insulin Dosing System is NDC.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 37873612 A European regulatory pathway for Tidepool loop following clearance in the United States? Diabetic medicine : a journal of the British Diabetic Association (2024)

Other Devices by Glooko, Inc.

K260910EndoTool IV Cloud 1.0

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

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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