510(k) · Cleared
Recalled · Class II · 2019ACCU-CHEK Connect Diabetes Management App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diabetes Care, Inc. · NDC Calculator, Drug Dose
Cleared on Jun 3, 2015 as substantially equivalent to K141929 (Roche Diagnostics Corporation, 2015) after a 61-day review. Its family tree reaches back 6 generations to 2001. 1 of the 45 devices in its family, counting itself, has a Class I recall. 32 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 3, 2015
- Review
- 61 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010362 (2001). 12 ancestors in all. 32 later devices descend from it, 3 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 4 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 3 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 2 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 1 generation backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- This deviceK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015
- Descendant · cites it directly · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- Descendant · cites it directly · 8 of its ownK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- Descendant · 3 generations on · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 6 of its ownK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology3 generations on · 2020
Most influential descendants
Showing 5 of 32 · See all- K160629InPenCompanion Medical, Inc. · 2016 · cites it directly21descendants
- K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · 2 generations on10descendants
- K161433Insulia Diabetes Management CompanionVoluntis Sa. · 2016 · cites it directly8descendants
- K201337InPen SystemCompanion Medical, Inc. · 2020 · 3 generations on7descendants
- K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −5 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −4 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −3 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −2 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −1 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| 0 (this device) | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | — |
| +1 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| +2 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| +1 | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| +3 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| +4 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 5 | 1 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K141929 | Accu-Chek Connect Diabetes Management AppSummary page 5…21 C.F.R. § 880.5725, 862.1345, 862.2100; Class II Product Code: LZG, LFR, JQP 3) Predicate ACCU-CHEK Connect Diabetes Management App (K141929), concurrence device received on March 16, 2015.… | 2015 |
What descends from it? (32)
See all 323 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2019 | Class II | Z-2753-2019 | Software in the Use Environment | Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. |
| Jun 8, 2017 | Class II | Z-0197-2018 | Software design | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not… |
| Jun 8, 2017 | Class II | Z-0625-2018 | Other | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This… |
| Mar 14, 2017 | Class II | Z-1899-2017 | Software design | A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery. |
| Dec 20, 2016 | Class II | Z-1099-2017 | Software design | iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple… |
| Sep 14, 2016 | Class II | Z-0586-2017 | Software design (manufacturing process) | Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor… |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 12 ancestors have a recall of any class.
- Of its descendants, K160629 (Companion Medical, Inc., 2016) has gone furthest, with 21 descendants of its own.
How does its category compare?
All NDC devicesNDC Calculator, Drug Dose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the…
Read the full statement (116 words)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150910: ACCU-CHEK Connect Diabetes Management App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150910
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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