Control-IQ+ technology
FDA 510(k) K243823 · Tandem Diabetes Care, Inc.
510(k) numberK243823
Submission
- Device name
- Control-IQ+ technology
- Applicant
- Tandem Diabetes Care, Inc.
San Diego, CA, US - Received
- December 12, 2024
- Decision date
- February 24, 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…
Other 510(k)s with product code QJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K251217 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | Medtronic Minimed, Inc. | 08/29/2025SE |
| K250798 | Control-IQ+ technologyQJI · Traditional | Tandem Diabetes Care, Inc. | 05/21/2025SE |
More from Tandem Diabetes Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260429 | Control-IQ+ technologyQJI · Traditional | 04/24/2026SE |
| K253074 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 11/06/2025SE |
| K250792 | t:slim X2 insulin pump with interoperable technologyQFG · Traditional | 09/24/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | 08/06/2025SE |
| K250798 | Control-IQ+ technologyQJI · Traditional | 05/21/2025SE |
| K241078 | Tandem Mobi Insulin Pump with interoperable technologyQFG · Traditional | 07/26/2024SE |
| K240309 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 03/21/2024SE |
| K232382 | Control-IQ TechnologyQJI · Traditional | 11/03/2023SE |
| K232380 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Traditional | 11/03/2023SE |
| K233044 | Tandem Mobi insulin pump with interoperable technologyQFG · Special | 10/05/2023SE |
Questions and answers
When was Control-IQ+ technology cleared by the FDA?
Control-IQ+ technology (K243823) received a 510(k) decision of Substantially Equivalent on February 24, 2025, 74 days after the submission was received.
What is the product code of K243823?
The FDA product code is QJI – Interoperable Automated Glycemic Controller, a Class II (moderate risk) device regulated under 21 CFR 862.1356.