# K201337: InPen System

- Pathway: 510(k) (Special)
- Applicant: Companion Medical, Inc.
- Decided: Jun 18, 2020 after 29 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 2 (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). 17 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 25 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.

## Most influential descendants
- 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
- K253743: MiniMed Flex pump (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
- Nov 8, 2022 · Class II · Z-0741-2023: Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displ

## Indications for use
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 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 under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data. 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/K201337
Methodology: https://510kreport.com/methodology