# K171450: Glooko Mobile Insulin Dosing System

- Pathway: 510(k) (Traditional)
- Applicant: Glooko, Inc.
- Decided: Feb 2, 2018 after 261 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010362 (2001). 15 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161433: Insulia Diabetes Management Companion, Voluntis Sa. (2016) Summary page 4.

## Most influential descendants
- K193654: BlueStar Rx (2020), 3 descendants of its own
- K203434: BlueStar Rx (2021), 1 descendant of its own
- K230813: BlueStar and BlueStar Rx (2023), 0 descendants of its own
- K221924: Digital Routines (2023), 0 descendants of its own

## Indications for use
The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Source page: https://510kreport.com/device/K171450
Methodology: https://510kreport.com/methodology