# K260062: MODI System

- Pathway: 510(k) (Traditional)
- Applicant: DreaMed Diabetes, Ltd.
- Decided: Sep 8, 2026 after 243 days
- Product code: QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator)
- Device class: 2
- Regulation: 21 CFR 862.1358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170043 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252818: Dexcom Smart Basal, Dexcom, Inc. (2025) Summary page 5.

## Indications for use
MODI insulin dose calculator is software intended for the management of type 2 diabetes in persons aged 18 years and older requiring long-acting insulin with or without rapid-acting insulin injections. MODI insulin dose calculator calculates a dose of basal (long-acting) insulin with or without a dose of bolus (rapid-acting for meal and correction) insulin based on glucose measurements from an iCGM (Integrated Continuous Glucose Monitor) and insulin delivery data (i.e. time of dose with or without amount of dose). MODI insulin dose calculator intended for single patient, home use and requires a prescription by a healthcare provider.

Source page: https://510kreport.com/device/K260062
Methodology: https://510kreport.com/methodology