# K160629: InPen

- Pathway: 510(k) (Traditional)
- Applicant: Companion Medical, Inc.
- Decided: Jul 26, 2016 after 141 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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: 7 generations back to K010362 (2001). 15 ancestors in all.
21 later devices descend from it; 5 cite it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123766: Novopen Echo, a Dial a Dose Insulin Delivery Pen, Novo Nordisk, Inc. (2013) Summary page 4.
- K150910: ACCU-CHEK Connect Diabetes Management App, Roche Diabetes Care, Inc. (2015) Summary page 4.

## Most influential descendants
- K190487: InPen Dose Calculator (2020), 10 descendants of its own
- 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
- K222689: Mallya Injection Pen Adapter (Mallya® for Solostar®) (2022), 4 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 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 of insulin 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 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 Novo Nordisk Novolog® U-100 3.0 mL cartridges of insulin 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/K160629
Methodology: https://510kreport.com/methodology