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FDA 510(k)

BlueStar CGM insulin dose calculator

K-Number: K222888 · 2023-08-11

ApplicantWelldoc, Inc.
Decision Date2023-08-11
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BlueStar CGM insulin dose calculator is the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K222888. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BlueStar CGM insulin dose calculator?

BlueStar CGM insulin dose calculator is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Welldoc, Inc.. The 510(k) number is K222888.

When did BlueStar CGM insulin dose calculator receive FDA 510(k) clearance?

BlueStar CGM insulin dose calculator received FDA 510(k) clearance on 2023-08-11, under 510(k) number K222888.

Who is the listed applicant for BlueStar CGM insulin dose calculator?

The FDA 510(k) record lists Welldoc, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BlueStar CGM insulin dose calculator?

The FDA product code for BlueStar CGM insulin dose calculator is QRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07652528CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP TrialNOT_YET_RECRUITINGNCT02438189Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive AlgorithmsCOMPLETEDNCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITINGNCT05947916Real Time Continuous Glucose Monitoring System in T2DM With PregnacyRECRUITINGNCT07611721Evaluate 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

Other records listing Welldoc, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230813BlueStar and BlueStar RxK203434BlueStar RxK193654BlueStar RxK190013WellDoc BlueStarK162532WellDoc BlueStar, WellDoc BlueStar RxK162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

View all 7 devices →

Related Devices (Code: QRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252818Dexcom Smart BasalDexcom, Inc.K231824SmartBolus CalculatorInsulet CorporationK222239SmartBolus CalculatorInsulet CorporationK203772Omnipod 5 SmartBolus CalculatorInsulet Corporation

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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