510(k) · Cleared
ClearedDiabetesmanager System, Diabetesmanager-RX System Model Version 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welldoc, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Jul 15, 2010 as substantially equivalent to K043529 (Roche Diagnostics Corp., 2005) and 1 other predicate after a 185-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 185 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001907 (2000). 4 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 1 generation backK080227 Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
- This deviceK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK162532 WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK190013 WellDoc BlueStarWelldoc, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK230813 BlueStar and BlueStar RxWelldoc, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017 · cites it directly5descendants
- K190013WellDoc BlueStarWelldoc, Inc. · 2019 · 2 generations on4descendants
- K193654BlueStar RxWelldoc, Inc. · 2020 · 3 generations on3descendants
- K203434BlueStar RxWelldoc, Inc. · 2021 · 4 generations on1descendant
- K230813BlueStar and BlueStar RxWelldoc, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −1 | K080227 | Accu-Chek 360 Diabetes Management System | Roche Diagnostics Corp. | 2008 | — |
| 0 (this device) | K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | Welldoc, Inc. | 2010 | — |
| +1 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017 | — |
| +2 | K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019 | — |
| +3 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +4 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
| +4 | K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K043529 | Accu-Chek Advisor Insulin Guidance SoftwareSummary page 5…LNX is unclassified and therefore has no regulation number 21 CFR 880.5725 (Infusion Pump) Medical computers and software Infusion pump II General Hospital LNX MRZ K043529 ACCU-CHEK®-Advisor Insulin Guidance Software K080227 ACCU-CHEK®-360° Diabetes Management System 36 /i TITLE: R… | 2005 |
| * | K080227 | Accu-Chek 360 Diabetes Management SystemSummary page 5…mber 21 CFR 880.5725 (Infusion Pump) Medical computers and software Infusion pump II General Hospital LNX MRZ K043529 ACCU-CHEK®-Advisor Insulin Guidance Software K080227 ACCU-CHEK®-360° Diabetes Management System 36 /i TITLE: Response to FDA Feedback on 510 (K) K100066 AL ® €2 Wr… | 2008 |
What descends from it? (8)
3 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 10 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K162532 (Welldoc, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K043529.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients — aged 21 years and older — who have type 2 diabetes. The DiabetesManager System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager System analyzes and reports blood glucose test results and supports medication adherence. It…
Read the full statement (269 words)
The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients — aged 21 years and older — who have type 2 diabetes. The DiabetesManager System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The DiabetesManager System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc DiabetesManager -Rx System is indicated for use by healthcare providers (HCPs) and their adult patients — aged 21 years and older — who have type 2 diabetes. The DiabetesManager-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager -Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager -Rx System provides coaching messages motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The DiabetesManager-Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
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/K100066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100066
Report an extraction error
Are you the manufacturer?
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