De Novo · Granted
GrantedDreaMed Advisor Pro
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
Granted on Jun 12, 2018 as a new device type through De Novo after a 299-day review. 10 later devices descend from it.
- Decided
- Jun 12, 2018
- Review
- 299 days
- Class
- Class II
- Product code
- QCC
- Recalls
- None
10 later devices descend from it, 1 citing it directly.
- This deviceDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- Descendant · cites it directly · 9 of its ownK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- Descendant · 4 generations on · 2 of its ownK222888 BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023
- Descendant · 5 generations on · 1 of its ownK252818 Dexcom Smart BasalDexcom, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K191370DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019 · cites it directly9descendants
- K201476DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020 · 2 generations on8descendants
- K203772Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022 · 3 generations on5descendants
- K222888BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023 · 4 generations on2descendants
- K252818Dexcom Smart BasalDexcom, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| +1 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| +2 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| +3 | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| +4 | K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023 | — |
| +5 | K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191370 | DreaMed Advisor Pro | 2019 | 9 |
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?
- Of its descendants, K191370 (DreaMed Diabetes, Ltd., 2019) has gone furthest, with 9 descendants of its own.
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. 2018, 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?
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…
Read the full statement (135 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170043 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170043: DreaMed Advisor Pro.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170043
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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