# K252104: T1D1

- Pathway: 510(k) (Traditional)
- Applicant: Comerge AG
- Decided: Aug 20, 2025 after 48 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181327: InPen Dose Calculator, Companion Medical, Inc. (2018) Summary page 5.

## Indications for use
The T1D1 mobile application is indicated for the management of diabetes by people with Type 1 diabetes age 2 and older by calculating insulin doses based on user-entered data. Prior to use, a healthcare professional must provide the patient target blood glucose values, insulin-to-carbohydrate ratios, and the correction factor (also known as the insulin sensitivity factor) to be programmed into the App software.

Source page: https://510kreport.com/device/K252104
Methodology: https://510kreport.com/methodology