# K191370: DreaMed Advisor Pro

- Pathway: 510(k) (Traditional)
- Applicant: DreaMed Diabetes, Ltd.
- Decided: Jul 18, 2019 after 57 days
- Product code: QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals)
- 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: 1 generation back to DEN170043 (2018). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170043: DreaMed Advisor Pro, DreaMed Diabetes, Ltd. (2018) Summary page 4.

## Most influential descendants
- K201476: DreaMed Advisor Pro (2020), 8 descendants of its own
- K203772: Omnipod 5 SmartBolus Calculator (2022), 5 descendants of its own
- 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

## Indications for use
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who: •use insulin pumps as their insulin delivery therapy; • monitor their glucose levels using CGM and/or self-management blood glucose meter; • are above the age of 6 and under 65 years old; and • use rapid acting U-100 insulin analogs in their pump. DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (SMBG) and pump data to generate recommendations for optimizing a patient’s insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.

Source page: https://510kreport.com/device/K191370
Methodology: https://510kreport.com/methodology