# K141929: Accu-Chek Connect Diabetes Management App

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corporation
- Decided: Mar 16, 2015 after 243 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010362 (2001). 11 ancestors in all.
33 later devices descend from it; 1 cites 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)
- K111353: Accu-Check Combo System, Roche Diagnostics (2012) Summary page 6.

## Most influential descendants
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own
- 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

## Recalls of this device
- Oct 30, 2014 · Class II · Z-1369-2015: Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough invest

## 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/K141929
Methodology: https://510kreport.com/methodology