510(k) · Cleared
Recalled · Class II · 2026Control-IQ+ technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care, Inc. · QJI Interoperable Automated Glycemic Controller
Cleared on May 21, 2025 as substantially equivalent to K243823 (Tandem Diabetes Care, Inc., 2025) after a 68-day review. Its family tree reaches back 4 generations to 2019. 1 later device descends from it. It has been recalled once.
- Decided
- May 21, 2025
- Review
- 68 days
- Class
- Class II
- Product code
- QJI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN190034 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- 3 generations backK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- 2 generations backK232382 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled
- 1 generation backK243823 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · Recalled
- This deviceK250798 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260429 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260429Control-IQ+ technologyTandem Diabetes Care, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −3 | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| −2 | K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023 | 1 |
| −1 | K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | 1 |
| 0 (this device) | K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | — |
| +1 | K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 QJI? 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 QJI device
- #1 K253701 SmartGuard Technology; Predictive Low Glucose…score 17.1 · 12 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 |
|---|---|---|---|
| * | K243823 | Control-IQ+ technologySummary page 5…fication Name Interoperable Automated Glycemic Controller Regulation Number 21 CFR 862.1356 Device Class Class II Predicate Device K243823, Control-IQ+ technology I. Device Under Review The Subject Device, Control-IQ+ technology (“Control-IQ+”) is a softwar… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260429 | Control-IQ+ technology | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2026 | Class II | Z-1636-2026 | Process change control | The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K260429 (Tandem Diabetes Care, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QJI
8so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJI
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJI
No recall names QJI since 2007.
Adverse event reports per year · QJI
3in 2025
MAUDE reports naming product code QJI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 4 | 251 | 0 | 26 |
| 2024 | 4 | 174 | 0 | 15 |
| 2025 | 5 | 130 | 0 | 3 |
| 2026 | 8 | 65 | 0 | — |
What is it indicated for?
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on ICGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
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/K250798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250798: Control-IQ+ technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250798
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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