# K203772: Omnipod 5 SmartBolus Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jan 27, 2022 after 400 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: 3 generations back to DEN170043 (2018). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201476: DreaMed Advisor Pro, DreaMed Diabetes, Ltd. (2020) Summary page 4.

## Most influential descendants
- K222888: BlueStar CGM insulin dose calculator (2023), 2 descendants of its own
- K252818: Dexcom Smart Basal (2025), 1 descendant of its own
- K222239: SmartBolus Calculator (2022), 1 descendant of its own
- K260062: MODI System (2026), 0 descendants of its own
- K231824: SmartBolus Calculator (2023), 0 descendants of its own

## Indications for use
The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.

Source page: https://510kreport.com/device/K203772
Methodology: https://510kreport.com/methodology