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FDA 510(k)

SmartAdjust™ Technology

K-Number: K241777 · 2024-08-26

Decision Date2024-08-26
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SmartAdjust™ Technology is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2024-08-26 under approval number K241777. 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™ Technology?

SmartAdjust™ Technology is a medical device that received FDA 510(k) clearance on 2024-08-26. It is manufactured by Insulet Corporation. The 510(k) number is K241777.

When was SmartAdjust™ Technology approved by the FDA?

SmartAdjust™ Technology received FDA 510(k) clearance on 2024-08-26, under approval number K241777.

What company makes SmartAdjust™ Technology?

SmartAdjust™ Technology is manufactured by Insulet Corporation.

What is the FDA product code for SmartAdjust™ Technology?

The FDA product code for SmartAdjust™ Technology is QJI.

Other Devices by Insulet Corporation

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Related Devices (Code: QJI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.