# K234055: DEKA Loop

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Mar 13, 2024 after 82 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 4.

## Indications for use
DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate controller enabled (ACE) insulin infusion pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user’s confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. DEKA Loop is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K234055
Methodology: https://510kreport.com/methodology