# K181327: InPen Dose Calculator

- Pathway: 510(k) (Special)
- Applicant: Companion Medical, Inc.
- Decided: Jul 6, 2018 after 49 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: 8 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)
- K160629: InPen, Companion Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K252104: T1D1 (2025), 0 descendants of its own

## Indications for use
The InPen dose calculator, a component of the InPen app. is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must 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/K181327
Methodology: https://510kreport.com/methodology