510(k) · Cleared
ClearedWellDoc BlueStar
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 Nov 4, 2019 as substantially equivalent to K162532 (Welldoc, Inc., 2017) after a 305-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 4, 2019
- Review
- 305 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001907 (2000). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
- 3 generations backK080227 Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
- 2 generations backK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
- 1 generation backK162532 WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
- This deviceK190013 WellDoc BlueStarWelldoc, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK230813 BlueStar and BlueStar RxWelldoc, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK221924 Digital RoutinesGnc Holdings, LLC · 2023
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001907 | Camit Diabetes Management Software | Roche Diagnostics Corp. | 2000 | — |
| −3 | K080227 | Accu-Chek 360 Diabetes Management System | Roche Diagnostics Corp. | 2008 | — |
| −2 | K100066 | Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 | Welldoc, Inc. | 2010 | — |
| −1 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017 | — |
| 0 (this device) | K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019 | — |
| +1 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +2 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
| +2 | K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023 | — |
| +3 | K221924 | Digital Routines | Gnc Holdings, LLC | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162532 | WellDoc BlueStar, WellDoc BlueStar RxSummary page 5…n 21 CFR 868.1890 – Calculator, Drug dose Regulatory Class: II Classification Panel: General Hospital Predicate Device: K162532 (WellDoc® BlueStar® and BlueStar® Rx System) Reference Device: K150910 (Accu-chek Connect Diabetes Management Applicatio… | 2017 |
| † | K150910 | ACCU-CHEK Connect Diabetes Management App | 2015 |
| † | DEN140038 | Continuous Glucose Monitor Secondary Display |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193654 | BlueStar Rx | 2020 | 3 |
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 19 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K193654 (Welldoc, Inc., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar 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 BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the…
Read the full statement (326 words)
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar 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 BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar 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 BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® 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 BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® 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. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.
The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190013: WellDoc BlueStar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190013
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