De Novo · Granted
GrantedControl-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
Granted on Dec 13, 2019 as a new device type through De Novo after a 151-day review. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Dec 13, 2019
- Review
- 151 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
17 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- Descendant · cites it directly · 15 of its ownK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- Descendant · 2 generations on · 7 of its ownK232382 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 3 of its ownK251217 SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025
- Descendant · 3 generations on · 2 of its ownK243823 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 2 of its ownK220916 iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technologycites it directly · 2020
Most influential descendants
Showing 5 of 17 · See all- K200467Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · cites it directly15descendants
- K232382Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · 2 generations on7descendants
- K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025 · 3 generations on3descendants
- K243823Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · 3 generations on2descendants
- K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| +1 | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| +2 | K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023 | 1 |
| +3 | K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025 | — |
| +3 | K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | 1 |
| +2 | K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
Sources: FDA De Novo 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 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (17)
See all 172 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)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K200467 (Tandem Diabetes Care, Inc., 2020) has gone furthest, with 15 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. 2019, 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 14 years of age and greater.
Control-IQ technology is intended for single patient use and requires a prescription.
Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190034 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190034: Control-IQ Technology.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190034
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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