510(k) · Cleared
ClearedGlooko Mobile Insulin Dosing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glooko, Inc. · NDC Calculator, Drug Dose
Cleared on Feb 2, 2018 as substantially equivalent to K161433 (Voluntis Sa., 2016) after a 261-day review. Its family tree reaches back 8 generations to 2001. 4 later devices descend from it.
- Decided
- Feb 2, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010362 (2001). 15 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 7 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 6 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 5 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 4 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 3 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 2 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 1 generation backK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- This deviceK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- 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 |
|---|---|---|---|---|---|
| −8 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −7 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −6 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −5 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −4 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −2 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −1 | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| 0 (this device) | K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018 | — |
| +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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K161433 | Insulia Diabetes Management CompanionSummary page 4…Classification Panel: General Hospital 5.3 Predicate Device Trade Name: Insulia Diabetes Management Companion (K161433) Common Name: Diabetes Management Software Classification Name: Calculator, Drug Do… | 2016 |
| † | K132272 | Glooko Device System for Glooko Application | 2013 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 15 ancestors have a recall of any class.
- Of its descendants, K193654 (Welldoc, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K161433.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171450: Glooko Mobile Insulin Dosing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171450
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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