Glooko Mobile Insulin Dosing System (Mids) Android & iOS Mobile Application

Glooko MIDS is a mobile insulin dose calculator for people with type 2 diabetes who follow a healthcare provider’s plan for adjusting long-acting basal insulin. The provider activates the…

Registry build 21.09.26

Glooko MIDS is a mobile insulin dose calculator for people with type 2 diabetes who follow a healthcare provider’s plan for adjusting long-acting basal insulin. The provider activates the calculator and configures patient-specific parameters before the patient uses the compatible Android or iOS application.

The patient interface gives directions within that preplanned treatment program. It obtains blood glucose data from compatible blood glucose meters; manual glucose entry is not supported. A separate provider interface in the Glooko web application lets the clinician prescribe the long-acting insulin regimen.

Listed Item

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.

Review Features

The system includes a logbook, reports and statistics, with internet data transfer. Its calculations support the configured plan and do not replace professional healthcare advice.

2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NDC
Manufacturer City Province Registered as Device types
Sanmina Kunshan Jiangsu Contract manufacturer 15
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44

Record

Regulatory record for Glooko Mobile Insulin Dosing System (Mids) Android & iOS Mobile Application
Listed by Glooko Inc, United States
FDA product code NDC
Device type Calculator, Drug Dose
Device class Class 2
Regulation 21 CFR 868.1890
Establishment Complaint-file establishment, Manufacturer
510(k) K171450
Record published 2018-06-22
Record revised 2026-07-21 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Glooko Mobile Insulin Dosing System (Mids) Android & iOS Mobile Application
Catalogue number Size Status
5.x In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welldoc Welldoc 16
Insulia Voluntis 6
Healthfirst Cares Rx Welldoc 6
Bluestar Welldoc 6
Healthfirst Cares Welldoc 5
Conifer Connect Diabetes Welldoc 5
Welldoc Rx Welldoc 5
LivingConnected Diabetes Rx Welldoc 5
Bluestar Rx Welldoc 5
Conifer Connect Diabetes Rx Welldoc 5
inpen™ Medtronic Minimed 5
TempoSmart Welldoc 4

Showing 12 of 36. All products under Calculator, Drug Dose

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K260910 2026-05-01
K171450 2018-02-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer