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FDA 510(k)

SmartAdjust(TM) technology

K-Number: K220394 · 2022-08-19

ApplicantInsulet Corporation
Decision Date2022-08-19
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SmartAdjust(TM) technology is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2022-08-19 under approval number K220394. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartAdjust(TM) technology?

SmartAdjust(TM) technology is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Insulet Corporation. The 510(k) number is K220394.

When was SmartAdjust(TM) technology approved by the FDA?

SmartAdjust(TM) technology received FDA 510(k) clearance on 2022-08-19, under approval number K220394.

What company makes SmartAdjust(TM) technology?

SmartAdjust(TM) technology is manufactured by Insulet Corporation.

What is the FDA product code for SmartAdjust(TM) technology?

The FDA product code for SmartAdjust(TM) technology is QJI.

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Related Devices (Code: QJI)

DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. K200467Control-IQ TechnologyTandem Diabetes Care, Inc. K203774SmartAdjust technologyInsulet Corporation K232382Control-IQ TechnologyTandem Diabetes Care, Inc. K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc. K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc.

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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