510(k) · Cleared
ClearedDreaMed 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
Cleared on Aug 28, 2020 as substantially equivalent to K191370 (DreaMed Diabetes, Ltd., 2019) after an 86-day review. Its family tree reaches back 2 generations to 2018. 8 later devices descend from it.
- Decided
- Aug 28, 2020
- Review
- 86 days
- Class
- Class II
- Product code
- QCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170043 (2018). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 1 generation backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- This deviceK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- Descendant · cites it directly · 5 of its ownK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK222888 BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK252818 Dexcom Smart BasalDexcom, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK222239 SmartBolus CalculatorInsulet Corporation · 2022
- Descendant · cites it directly · 1 of its ownK210561 Advisor Pro PlatformDreaMed Diabetes, Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203772Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022 · cites it directly5descendants
- K222888BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023 · 2 generations on2descendants
- K252818Dexcom Smart BasalDexcom, Inc. · 2025 · 3 generations on1descendant
- K222239SmartBolus CalculatorInsulet Corporation · 2022 · 2 generations on1descendant
- K210561Advisor Pro PlatformDreaMed Diabetes, Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −1 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| 0 (this device) | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| +1 | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| +2 | K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023 | — |
| +3 | K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025 | — |
| +2 | K222239 | SmartBolus Calculator | Insulet Corporation | 2022 | — |
| +1 | K210561 | Advisor Pro Platform | DreaMed Diabetes, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K191370 | DreaMed Advisor ProSummary page 4…Usual Name Insulin Therapy Adjustment Device Classification Class II, 21 CFR 862.1358, Product Code: QCC Predicate Devices DreaMed Advisor Pro, K191370 Intended Use / Indications for Use DreaMed Advisor Pro is a decision-support software intended for assisting healthcare… | 2019 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203772 (Insulet Corporation, 2022) has gone furthest, with 5 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. 2020, 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 continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; • are above the age of 6; and • use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for…
Read the full statement (120 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 continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter;
• are above the age of 6; and
• use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, 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 judgement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201476: DreaMed Advisor Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201476
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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