SmartGuard technology; Predictive Low Glucose technology
FDA 510(k) K251217 · Medtronic Minimed, Inc.
Submission
- Device name
- SmartGuard technology; Predictive Low Glucose technology
- Applicant
- Medtronic Minimed, Inc.
Northridge, CA, US - Received
- April 21, 2025
- Decision date
- August 29, 2025
- 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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|---|---|---|---|
| K262763 | iLet Dosing Decision SoftwareQJI · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K261962 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Special | Medtronic MiniMed | 07/09/2026SE |
| K261461 | Omnipod 6 algorithmQJI · Traditional | Insulet Corporation | 06/29/2026SE |
| K260429 | Control-IQ+ technologyQJI · Traditional | Tandem Diabetes Care, Inc. | 04/24/2026SE |
| K253701 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Traditional | Medtronic Minimed | 02/03/2026SE |
| K253585 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | Medtronic Minimed, Inc. | 01/14/2026SE |
| K251152 | DBLG2QJI · Traditional | Diabeloop | 12/19/2025SE |
| K251779 | Omnipod 5 algorithmQJI · Traditional | Insulet Corporation | 12/03/2025SE |
| K250798 | Control-IQ+ technologyQJI · Traditional | Tandem Diabetes Care, Inc. | 05/21/2025SE |
| K243823 | Control-IQ+ technologyQJI · Traditional | Tandem Diabetes Care, Inc. | 02/24/2025SE |
More from Tandem Diabetes Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Special | 07/09/2026SE |
| K253743 | MiniMed Flex pumpQFG · Traditional | 03/12/2026SE |
| K253701 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Traditional | 02/03/2026SE |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | 01/15/2026SE |
| K253585 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | 01/14/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | 01/08/2026SE |
| K251032 | MiniMed 780G insulin pumpQFG · Traditional | 07/01/2025SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | 11/12/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | 07/02/2024SE |
| K210714 | Extended ReservoirLZG · Traditional | 04/06/2022SE |
Questions and answers
When was SmartGuard technology; Predictive Low Glucose technology cleared by the FDA?
SmartGuard technology; Predictive Low Glucose technology (K251217) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 130 days after the submission was received.
What is the product code of K251217?
The FDA product code is QJI – Interoperable Automated Glycemic Controller, a Class II (moderate risk) device regulated under 21 CFR 862.1356.