510(k) · Cleared
ClearedBlueStar Rx
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 Apr 7, 2020 as substantially equivalent to K190013 (Welldoc, Inc., 2019) and 1 other predicate after a 99-day review. Its family tree reaches back 9 generations to 2001. 3 later devices descend from it.
- Decided
- Apr 7, 2020
- Review
- 99 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010362 (2001). 23 ancestors in all, the oldest K001907 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations between
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- 1 generation backK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- This deviceK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK230813 BlueStar and BlueStar RxWelldoc, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK221924 Digital RoutinesGnc Holdings, LLC · 2023
Show all 9 generations
- Root · 9 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 8 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 7 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 6 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 5 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 4 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 3 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 2 generations backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- 1 generation backK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- This deviceK193654 BlueStar RxWelldoc, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −8 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −7 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −6 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −5 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −3 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −2 | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| −1 | K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018 | — |
| 0 (this device) | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +1 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
| +1 | K230813 | BlueStar and BlueStar Rx | Welldoc, Inc. | 2023 | — |
| +2 | K221924 | Digital Routines | Gnc Holdings, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K230718 UTC 3mL Medication Cartridgescore 5.5 · 1 generation · 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 |
|---|---|---|---|
| * | K190013 | WellDoc BlueStarSummary page 5…21 CFR 868.1890 – Calculator, Drug dose Regulatory Class: II Classification Panel: General Hospital, Clinical Chemistry Primary Predicate Device: K190013 (WellDoc® BlueStar® and WellDoc® BlueStar® Rx System) Secondary Predicate Device: K171450 (Glooko Mobile Insulin Dosing System (… | 2019 |
| * | K171450 | Glooko Mobile Insulin Dosing SystemSummary page 5…nel: General Hospital, Clinical Chemistry Primary Predicate Device: K190013 (WellDoc® BlueStar® and WellDoc® BlueStar® Rx System) Secondary Predicate Device: K171450 (Glooko Mobile Insulin Dosing System (MIDS)) Device Description BlueStar Rx is a modified version of the primary predicate (We… | 2018 |
What descends from it? (3)
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 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 23 ancestors have a recall of any class.
- Of its descendants, K203434 (Welldoc, Inc., 2021) has gone furthest, with 1 descendant 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. 2020, 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?
BlueStar® Rx 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 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx provides coaching…
Read the full statement (245 words)
BlueStar® Rx 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 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx 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.
• For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.
• For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters.
The BlueStar® Rx 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/K193654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193654: BlueStar Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193654
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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