510(k) · Cleared
Clearedendo.digital Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DreaMed Diabetes, Ltd. · QCC Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Cleared on Oct 3, 2023 as substantially equivalent to K210561 (DreaMed Diabetes, Ltd., 2021) after a 28-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Oct 3, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170043 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 3 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 2 generations backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- 1 generation backK210561 Advisor Pro PlatformDreaMed Diabetes, Ltd. · 2021
- This deviceK232722 endo.digital PlatformDreaMed Diabetes, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −3 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −2 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| −1 | K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | 2021 | — |
| 0 (this device) | K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QCC device
- #1 K201476 DreaMed Advisor Proscore 6.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210561 | Advisor Pro PlatformSummary page 5…ification Class II, 21 CFR 862.1358, Product Code: QCC, Class II, 21 CFR 868.1890, Product Code: NDC. Predicate Devices Advisor Pro Platform, K210561 Intended Use / Indications for Use endo.digital Platform endo.digital Platform is intended for the management of diabetes by… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QCC devicesQCC Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QCC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QCC
Too few QCC 510(k)s in any year since 2007 to give a median.
Recalls per year · QCC
No recall names QCC since 2007.
Adverse event reports per year · QCC
No MAUDE report names QCC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (365 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232722: endo.digital Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232722
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026