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510(k) K203772

Device
Omnipod 5 SmartBolus Calculator
Applicant
Insulet Corporation
510(k) number
K203772
Product code
QRX  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-27
Date received
2020-12-23
Regulation
862.1358
Classification name
Continuous Glucose Monitor Informed Insulin Dose Calculator
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Julie Perkins
Address
100 Nagog Park Acton MA US 01720 01720

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QRX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252818Dexcom Smart BasalDexcom, Inc.2025-11-18
K231824SmartBolus CalculatorInsulet Corporation2023-10-18
K222888BlueStar CGM insulin dose calculatorWelldoc, Inc.2023-08-11
K222239SmartBolus CalculatorInsulet Corporation2022-08-19

Legacy Summary#

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FDA Review#

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