# K192841: InPen System

- Pathway: 510(k) (Traditional)
- Applicant: Companion Medical, Inc.
- Decided: Feb 10, 2020 after 130 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.
No later device cites it as a predicate yet.
0 of 17 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.

## 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 is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. 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/K192841
Methodology: https://510kreport.com/methodology