# K203689: Tidepool Loop

- Pathway: 510(k) (Traditional)
- Applicant: Tidepool Project
- Decided: Jan 23, 2023 after 767 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: 2 generations back to DEN190034 (2019). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200467: Control-IQ Technology, Tandem Diabetes Care, Inc. (2020) Summary page 5.

## Most influential descendants
- K251152: DBLG2 (2025), 0 descendants of its own
- K234055: DEKA Loop (2024), 0 descendants of its own

## Indications for use
Tidepool Loop, 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 recommend, and with the user’s confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. Tidepool Loop is intended for single patient use. Tidepool Loop is Rx - For Prescription Use Only.

Source page: https://510kreport.com/device/K203689
Methodology: https://510kreport.com/methodology