# K231824: SmartBolus Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Oct 18, 2023 after 119 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222239: SmartBolus Calculator, Insulet Corporation (2022) Summary page 4.

## Indications for use
The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (JOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.

Source page: https://510kreport.com/device/K231824
Methodology: https://510kreport.com/methodology