# K150910: ACCU-CHEK Connect Diabetes Management App

- Pathway: 510(k) (Special)
- Applicant: Roche Diabetes Care, Inc.
- Decided: Jun 3, 2015 after 61 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010362 (2001). 12 ancestors in all.
32 later devices descend from it; 3 cite it directly.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141929: Accu-Chek Connect Diabetes Management App, Roche Diagnostics Corporation (2015) Summary page 5.

## Most influential descendants
- K160629: InPen (2016), 21 descendants of its own
- K190487: InPen Dose Calculator (2020), 10 descendants of its own
- K161433: Insulia Diabetes Management Companion (2016), 8 descendants of its own
- K201337: InPen System (2020), 7 descendants of its own
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (2024), 6 descendants of its own

## Recalls of this device
- May 3, 2019 · Class II · Z-2753-2019: Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
- Jun 8, 2017 · Class II · Z-0197-2018: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in w
- Jun 8, 2017 · Class II · Z-0625-2018: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within t
- Mar 14, 2017 · Class II · Z-1899-2017: A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
- Dec 20, 2016 · Class II · Z-1099-2017: iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS
- Sep 14, 2016 · Class II · Z-0586-2017: Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming

## Indications for use
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.

Source page: https://510kreport.com/device/K150910
Methodology: https://510kreport.com/methodology