# K232451: Insulia Bolus Companion

- Pathway: 510(k) (Traditional)
- Applicant: Voluntis Sa.
- Decided: Dec 12, 2023 after 120 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: 9 generations back to K010362 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190487: InPen Dose Calculator, Companion Medical, Inc. (2020) Summary page 4.

## Indications for use
The Insulia Bolus Companion is indicated for the management of diabetes by adults with diabetes, by calculating an insulin dose or suggesting carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide a patient-specific target blood glucose, insulin doses based on fixed or variable meal sizes, and insulin sensitivity parameters to be programmed into the software. This can be done through a dedicated, secured web portal.

Source page: https://510kreport.com/device/K232451
Methodology: https://510kreport.com/methodology