# K252818: Dexcom Smart Basal

- Pathway: 510(k) (Traditional)
- Applicant: Dexcom, Inc.
- Decided: Nov 18, 2025 after 75 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: 5 generations back to DEN170043 (2018). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222888: BlueStar CGM insulin dose calculator, Welldoc, Inc. (2023) Summary page 5.

## Most influential descendants
- K260062: MODI System (2026), 0 descendants of its own

## Indications for use
The Dexcom Smart Basal insulin dose calculator is software intended for the management of type 2 diabetes in persons aged 18 years and older requiring long-acting insulin. This is not for use for patients on fast-acting insulin. The Dexcom Smart Basal insulin dose calculator calculates a dose of basal (long-acting) insulin using logged doses and glucose measurements from an integrated continuous glucose monitor (iCGM). The Dexcom Smart Basal insulin dose calculator requires a prescription and initial configuration by a healthcare provider.

Source page: https://510kreport.com/device/K252818
Methodology: https://510kreport.com/methodology