510(k) · Cleared
ClearedAdvisor Pro 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 Sep 28, 2021 as substantially equivalent to K201476 (DreaMed Diabetes, Ltd., 2020) after a 215-day review. Its family tree reaches back 3 generations to 2018. 1 later device descends from it.
- Decided
- Sep 28, 2021
- Review
- 215 days
- Class
- Class II
- Product code
- QCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170043 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 2 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 1 generation backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- This deviceK210561 Advisor Pro PlatformDreaMed Diabetes, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232722 endo.digital PlatformDreaMed Diabetes, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232722endo.digital PlatformDreaMed Diabetes, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −2 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −1 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| 0 (this device) | K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | 2021 | — |
| +1 | K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 K232722 endo.digital Platformscore 7.0 · 4 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 |
|---|---|---|---|
| * | K201476 | DreaMed Advisor ProSummary page 5…Name Insulin Therapy Adjustment Device Classification Class II, 21 CFR 862.1358, Product Code: QCC Predicate Devices DreaMed Advisor Pro, K201476 Reference Device: Accu-Chek Connect Diabetes Management App, Roche Diabetes Care Inc., K150910 Intended Use / In… | 2020 |
| † | K150910 | ACCU-CHEK Connect Diabetes Management App | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232722 | endo.digital Platform | 2023 | 0 |
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 3 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232722 (DreaMed Diabetes, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201476.
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. 2021, 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?
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…
Read the full statement (386 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210561: Advisor Pro Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210561
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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