510(k) · Cleared
ClearedInsulia Diabetes Management Companion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voluntis Sa. · NDC Calculator, Drug Dose
Cleared on Nov 9, 2016 as substantially equivalent to K150910 (Roche Diabetes Care, Inc., 2015) and 1 other predicate after a 169-day review. Its family tree reaches back 7 generations to 2001. 8 later devices descend from it.
- Decided
- Nov 9, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- NDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010362 (2001). 14 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 6 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 5 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 4 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 3 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 2 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 1 generation backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- This deviceK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- Descendant · cites it directly · 4 of its ownK171450 Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK193654 BlueStar RxWelldoc, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK170669 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK203434 BlueStar RxWelldoc, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK172177 Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K171450Glooko Mobile Insulin Dosing SystemGlooko, Inc. · 2018 · cites it directly4descendants
- K193654BlueStar RxWelldoc, Inc. · 2020 · 2 generations on3descendants
- K170669Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · cites it directly2descendants
- K203434BlueStar RxWelldoc, Inc. · 2021 · 3 generations on1descendant
- K172177Insulia Diabetes Management CompanionVoluntis Sa. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −6 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −5 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −4 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −3 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −2 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −1 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| 0 (this device) | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| +1 | K171450 | Glooko Mobile Insulin Dosing System | Glooko, Inc. | 2018 | — |
| +2 | K193654 | BlueStar Rx | Welldoc, Inc. | 2020 | — |
| +1 | K170669 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017 | 1 |
| +3 | K203434 | BlueStar Rx | Welldoc, Inc. | 2021 | — |
| +2 | K172177 | Insulia Diabetes Management Companion | Voluntis Sa. | 2017 | 1 |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | K150910 | ACCU-CHEK Connect Diabetes Management AppSummary page 4…Trade Name: ACCU-CHEK Connect Diabetes Management App 510(k) Reference: K150910 Common Name: Diabetes Management Software Regulation Number: 21 CFR 8… | 2015 |
| * | K141273 | Welldoc Diabetesmanager System and Diabetesmanager- RX SysteSummary page 5…DiabetesManager® System and DiabetesManager®-Rx System) 510(k) Reference: K141273 Common Name: Medical computers and software Infusi… | 2014 |
What descends from it? (8)
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 15 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 14 ancestors have a recall of any class.
- Of its descendants, K171450 (Glooko, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K150910.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog. Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of…
Read the full statement (180 words)
Insulia Diabetes Management Companion is indicated for use by healthcare professionals (HCPs) and their type 2 adult diabetes patients treated with long-acting insulin analog.
Insulia Diabetes Management Companion is intended to provide secure capture, storage and transmission of diabetes-related healthcare information, to enhance data management, to display reports and graphs, and to aid the HCP and the patient in the review, analysis, and evaluation of patient data in order to support effective diabetes management.
Insulia Diabetes Management Companion includes a basal calculator intended to provide direction to the patient in response to blood glucose and health events, within the scope of a pre-planned treatment program from a healthcare professional for insulin adjustments, similar to the directions provided to patients as a part of routine clinical practice.
Insulia Diabetes Management Companion includes software intended for use on commercially available mobile platforms, personal computers, in the home or in professional healthcare settings, and uses generally available networks and communication protocols.
Insulia Diabetes Management Companion 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/K161433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161433: Insulia Diabetes Management Companion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161433
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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