SmartAdjust Technology
FDA 510(k) K241777 · Insulet Corporation
510(k) numberK241777
Submission
- Device name
- SmartAdjust Technology
- Applicant
- Insulet Corporation
Acton, MA, US - Received
- June 20, 2024
- Decision date
- August 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJI – Interoperable Automated Glycemic Controller
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1356
- Specialty
- Clinical Chemistry
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow…
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More from Tandem Diabetes Care, Inc.
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|---|---|---|
| K261461 | Omnipod 6 algorithmQJI · Traditional | 06/29/2026SE |
| K251779 | Omnipod 5 algorithmQJI · Traditional | 12/03/2025SE |
| K232741 | SmartAdjust(TM) technologyQJI · Traditional | 05/29/2024SE |
| K231826 | Omnipod 5 ACE PumpQFG · Traditional | 10/18/2023SE |
| K231824 | SmartBolus CalculatorQRX · Traditional | 10/18/2023SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | 04/24/2023SE |
| K222239 | SmartBolus CalculatorQRX · Traditional | 08/19/2022SE |
| K220394 | SmartAdjust(TM) technologyQJI · Traditional | 08/19/2022SE |
| K203774 | SmartAdjust technologyQJI · Traditional | 01/27/2022SE |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | 01/27/2022SE |
Questions and answers
When was SmartAdjust Technology cleared by the FDA?
SmartAdjust Technology (K241777) received a 510(k) decision of Substantially Equivalent on August 26, 2024, 67 days after the submission was received.
What is the product code of K241777?
The FDA product code is QJI – Interoperable Automated Glycemic Controller, a Class II (moderate risk) device regulated under 21 CFR 862.1356.