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FDA 510(k)

Omnipod 5 SmartBolus Calculator

K-Number: K203772 · 2022-01-27

ApplicantInsulet Corporation
Decision Date2022-01-27
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Omnipod 5 SmartBolus Calculator is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K203772. 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 Omnipod 5 SmartBolus Calculator?

Omnipod 5 SmartBolus Calculator is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Insulet Corporation. The 510(k) number is K203772.

When did Omnipod 5 SmartBolus Calculator receive FDA 510(k) clearance?

Omnipod 5 SmartBolus Calculator received FDA 510(k) clearance on 2022-01-27, under 510(k) number K203772.

Who is the listed applicant for Omnipod 5 SmartBolus Calculator?

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

What is the FDA product code for Omnipod 5 SmartBolus Calculator?

The FDA product code for Omnipod 5 SmartBolus 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.

NCT06144554Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesRECRUITINGNCT07039942French Prospective Multicentric Study in Real WorldACTIVE_NOT_RECRUITINGNCT07039981Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesCOMPLETEDNCT07317102Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)RECRUITINGNCT07521475Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesRECRUITINGNCT07579702Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 SystemRECRUITING

Other records listing Insulet Corporation 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.

K261461Omnipod 6 algorithmK251779Omnipod 5 algorithmK241777SmartAdjust™ TechnologyK232741SmartAdjust(TM) technologyK231826Omnipod 5 ACE PumpK231824SmartBolus Calculator

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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 CorporationK222888BlueStar CGM insulin dose calculatorWelldoc, Inc.K222239SmartBolus 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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