510(k) · Cleared
ClearedAccu-Chek Advisor Insulin Guidance Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NDC Calculator, Drug Dose
Cleared on Apr 8, 2005 after a 108-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Apr 8, 2005
- Review
- 108 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK043529 Accu-Chek Advisor Insulin Guidance SoftwareRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 8 of its ownK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK162532 WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK190013 WellDoc BlueStarWelldoc, Inc. · 2019
- Descendant · 4 generations on · 3 of its ownK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · 5 generations on · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010 · cites it directly8descendants
- K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017 · 2 generations on5descendants
- K190013WellDoc BlueStarWelldoc, Inc. · 2019 · 3 generations on4descendants
- K193654BlueStar RxWelldoc, Inc. · 2020 · 4 generations on3descendants
- K203434BlueStar RxWelldoc, Inc. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043529 | Accu-Chek Advisor Insulin Guidance Software | Roche Diagnostics Corp. | 2005 | — |
| +1 | K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | Welldoc, Inc. | 2010 | — |
| +2 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017 | — |
| +3 | K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019 | — |
| +4 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +5 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 NDC? 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 NDC device
- #1 K242775 InPen System App (MMT-8060 (iOS), MMT-8061…score 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | — | Diacare Monitoring System Software Named without a submission number |
What descends from it? (10)
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?
- Of its descendants, K100066 (Welldoc, Inc., 2010) has gone furthest, with 8 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDC
60in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDC
299in 2025
MAUDE reports naming product code NDC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 3 | 118 | 0 | 1 |
| 2015 | 3 | 199 | 0 | 1 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 8 | 189 | 2 | 25 |
| 2018 | 3 | 220 | 1 | 21 |
| 2019 | 1 | — | 1 | 18 |
| 2020 | 5 | 53 | 0 | 10 |
| 2021 | 3 | 269 | 0 | 11 |
| 2022 | 0 | — | 1 | 347 |
| 2023 | 3 | 126 | 0 | 463 |
| 2024 | 3 | 60 | 0 | 168 |
| 2025 | 2 | — | 1 | 299 |
| 2026 | 4 | 90 | 2 | — |
What is it indicated for?
The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K043529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043529: Accu-Chek Advisor Insulin Guidance Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043529
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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