# K172177: Insulia Diabetes Management Companion

- Pathway: 510(k) (Traditional)
- Applicant: Voluntis Sa.
- Decided: Nov 7, 2017 after 111 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: 9 generations back to K010362 (2001). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170669: Insulia Diabetes Management Companion, Voluntis Sa. (2017) Summary page 4.

## Most influential descendants
- K202596: Insulia Diabetes Management Companion (2021), 0 descendants of its own

## Recalls of this device
- Oct 8, 2018 · Class II · Z-0478-2019: The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the cir

## Indications for use
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management. Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice. Insulia Diabetes Management Companion includes software intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols. Insulia Diabetes Management Companion is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Source page: https://510kreport.com/device/K172177
Methodology: https://510kreport.com/methodology