# K190487: InPen Dose Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Companion Medical, Inc.
- Decided: Feb 18, 2020 after 355 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: 8 generations back to K010362 (2001). 16 ancestors in all.
10 later devices descend from it; 3 cite it directly.
1 of 27 devices in its family (counting itself) has 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
- 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
- K251032: MiniMed 780G insulin pump (2025), 4 descendants of its own
- K253701: SmartGuard Technology; Predictive Low Glucose Technology (2026), 1 descendant of its own
- K261962: SmartGuard Technology; Predictive Low Glucose Technology (2026), 0 descendants of its own

## Recalls of this device
- Mar 4, 2025 · Class II · Z-1650-2025: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be dif

## 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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin. For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

Source page: https://510kreport.com/device/K190487
Methodology: https://510kreport.com/methodology