DBLG2
FDA 510(k) K251152 · Diabeloop
510(k) numberK251152
Submission
- Device name
- DBLG2
- Applicant
- Diabeloop
Grenoble, FR - Received
- April 14, 2025
- Decision date
- December 19, 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 |
| 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 |
| K243823 | Control-IQ+ technologyQJI · Traditional | Tandem Diabetes Care, Inc. | 02/24/2025SE |
Questions and answers
When was DBLG2 cleared by the FDA?
DBLG2 (K251152) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 249 days after the submission was received.
What is the product code of K251152?
The FDA product code is QJI – Interoperable Automated Glycemic Controller, a Class II (moderate risk) device regulated under 21 CFR 862.1356.