510(k) · Cleared
ClearedControl-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 Apr 24, 2026 as substantially equivalent to K250798 (Tandem Diabetes Care, Inc., 2025) after a 73-day review. Its family tree reaches back 5 generations to 2019.
- Decided
- Apr 24, 2026
- Review
- 73 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN190034 (2019). No later device cites it as a predicate yet.
- Root · 5 generations backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- 4 generations backK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- 3 generations backK232382 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled
- 2 generations backK243823 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · Recalled
- 1 generation backK250798 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · Recalled
- This deviceK260429 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −4 | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| −3 | K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023 | 1 |
| −2 | K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | 1 |
| −1 | K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | 1 |
| 0 (this device) | K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K250798 | Control-IQ+ technologySummary page 5…ble Automated Glycemic Controller Regulation Number 21 CFR 862.1356 Device Class Class II Predicate Device K250798, Control-IQ+ technology I. Device Under Review The Subject Device, Control-IQ+ technology (“Control-IQ+”) is a soft… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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…
Read the full statement (125 words)
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 use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy.
Control-IQ+ technology is intended for single patient use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260429: 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/K260429
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026