# K232722: endo.digital Platform

- Pathway: 510(k) (Special)
- Applicant: DreaMed Diabetes, Ltd.
- Decided: Oct 3, 2023 after 28 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: 4 generations back to DEN170043 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210561: Advisor Pro Platform, DreaMed Diabetes, Ltd. (2021) Summary page 5.

## Indications for use
endo.digital Platform endo.digital Platform is intended for the management of diabetes by people with diabetes and their healthcare providers in order to report, upload, log, track, share, monitor and review their data using web and mobile applications. endo.digital Platform also enables communication between people with diabetes and their healthcare providers as well as among healthcare providers. endo.digital Platform enables the healthcare provider to use endo.digital Algorithm for treatment recommendations as described below and prescribe endo.digital Bolus Calculator for patient use. endo.digital Algorithm endo.digital 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: - Long acting insulins (for injections only) - Short acting insulins: • Rapid acting analogs (for injections and insulin pump according to manufacturer indications for use) • Regular human insulin (for injections only) endo.digital 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. endo.digital 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. endo.digital Algorithm does not replace clinical judgement. endo.digital Bolus Calculator endo.digital 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/K232722
Methodology: https://510kreport.com/methodology