510(k) · Cleared
Recalled · Class II · 2014Accu-Chek Connect Diabetes Management App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corporation · NDC Calculator, Drug Dose
Cleared on Mar 16, 2015 as substantially equivalent to K111353 (Roche Diagnostics, 2012) after a 243-day review. Its family tree reaches back 5 generations to 2001. 1 of the 45 devices in its family, counting itself, has a Class I recall. 33 later devices descend from it. It has been recalled once.
- Decided
- Mar 16, 2015
- Review
- 243 days
- Class
- Class II
- Product code
- NDC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010362 (2001). 11 ancestors in all. 33 later devices descend from it, 1 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 4 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 3 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 2 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 1 generation backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- This deviceK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015
- Descendant · cites it directly · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 8 of its ownK161433 Insulia Diabetes Management CompanionVoluntis Sa. · 2016
- Descendant · 4 generations on · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology4 generations on · 2020
Most influential descendants
Showing 5 of 33 · See all- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · cites it directly32descendants
- K160629InPenCompanion Medical, Inc. · 2016 · 2 generations on21descendants
- K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · 3 generations on10descendants
- K161433Insulia Diabetes Management CompanionVoluntis Sa. · 2016 · 2 generations on8descendants
- K201337InPen SystemCompanion Medical, Inc. · 2020 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −4 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −3 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −2 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −1 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| 0 (this device) | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | — |
| +1 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| +2 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| +3 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| +2 | K161433 | Insulia Diabetes Management Companion | Voluntis Sa. | 2016 | — |
| +4 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K111353 | Accu-Check Combo SystemSummary page 6…1/8 510(k) Summary, Continued 3) Predicate ACCU-CHEK Aviva Combo meter, cleared as a component of the ACCU- device CHEK Combo System in #k111353. The ACCU-CHEK Combo System consists of three (3) main components: • ACCU-CHEK Aviva Combo b… | 2012 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150910 | ACCU-CHEK Connect Diabetes Management App | 2015 | 32 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2014 | Class II | Z-1369-2015 | Software design | Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that… |
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 · 4 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 3 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 11 ancestors have a recall of any class.
- Of its descendants, K150910 (Roche Diabetes Care, Inc., 2015) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K111353.
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/K141929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141929: 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/K141929
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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