# K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Nov 12, 2024 after 60 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K010362 (2001). 18 ancestors in all.
6 later devices descend from it; 3 cite 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)
- K201337: InPen System, Companion Medical, Inc. (2020) Summary page 5.

## Most influential descendants
- 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
- K253470: MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (2026), 0 descendants of its own

## Recalls of this device
- Nov 13, 2025 · Class II · Z-0958-2026: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone sett
- Jun 16, 2025 · Class II · Z-2496-2025: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a 
- 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 System is a home-use reusable pen for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient aged 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 Smart Insulin pen 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 aged 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/K242775
Methodology: https://510kreport.com/methodology