# DEN170043: DreaMed Advisor Pro

- Pathway: De Novo (Direct)
- Applicant: DreaMed Diabetes, Ltd.
- Decided: Jun 12, 2018 after 299 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
No predicates in its family tree.
10 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K191370: DreaMed Advisor Pro (2019), 9 descendants of its own
- 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

## 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 either of the following: o CGM, or o CGM and 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 judgment.

Source page: https://510kreport.com/device/DEN170043
Methodology: https://510kreport.com/methodology