# K251152: DBLG2

- Pathway: 510(k) (Traditional)
- Applicant: Diabeloop
- Decided: Dec 19, 2025 after 249 days
- Product code: QJI (Interoperable Automated Glycemic Controller)
- Device class: 2
- Regulation: 21 CFR 862.1356
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN190034 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203689: Tidepool Loop, Tidepool Project (2023) Summary page 6.

## Indications for use
DBLG2, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when glucose values are predicted to exceed a predefined threshold. To do this, the DBLG2 software takes into account the patient's profile, glycemia (current and predicted), announced meals and physical activities. DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater. DBLG2 is intended for single patient use. DBLG2 is Rx - For Prescription Use Only.

Source page: https://510kreport.com/device/K251152
Methodology: https://510kreport.com/methodology