# K210561: Advisor Pro Platform

- Pathway: 510(k) (Traditional)
- Applicant: DreaMed Diabetes, Ltd.
- Decided: Sep 28, 2021 after 215 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: 3 generations back to DEN170043 (2018). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 5.

## Most influential descendants
- K232722: endo.digital Platform (2023), 0 descendants of its own

## Indications for use
Advisor Pro Platform The Advisor Pro Platform is intended for the management of diabetes by people with diabetes and their health care providers in order to report, log, track, share, monitor and review their data using the dedicated computer or mobile software. Advisor Pro Platform also enables communication between people with diabetes and their health care providers as well as among health care providers. The Advisor Pro Platform enables the healthcare provider to use the Advisor Pro Algorithms for treatment recommendations as described below and prescribe the Advisor Pro Bolus Calculator for patient use. Advisor Pro Algorithm Advisor Pro Algorithm is a decision-support software intended for assisting healthcare professionals in the management of their patients with diabetes who monitor their glucose levels using continuous glucose monitor (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; and use any of the following insulin types as their therapy to manage glucose levels via subcutaneous injections or continuous sub-cutaneous insulin infusion (CSII; insulin pump) reported either manually or automatically: o Long Acting insulins (for injections only) o Short acting insulins: • Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use) • Regular human insulin (for injections only) The Advisor Pro algorithm is intended to be used for patients with: • Type 1 diabetes over the age of 6 using an insulin pump or subcutaneous insulin injections. • Type 2 diabetes over the age of 10 who use subcutaneous insulin injections. Advisor Pro Algorithm is indicated for use by healthcare professionals when analyzing CGM, SMBG and/or insulin delivery data to generate recommendations for optimizing a patient’s insulin treatment plan for basal therapy and/or bolus therapy and/or glucose targets; without considering the full clinical status of a particular patient. Advisor Pro Algorithm does not replace clinical judgment. Advisor Pro Bolus Calculator The Advisor Pro Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information. The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.

Source page: https://510kreport.com/device/K210561
Methodology: https://510kreport.com/methodology