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 Jun 16, 2020 as substantially equivalent to DEN190034 (Tandem Diabetes Care, Inc., 2019) after a 111-day review. Its family tree reaches back 1 generation to 2019. 15 later devices descend from it.
- Decided
- Jun 16, 2020
- Review
- 111 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190034 (2019). 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- This deviceK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK232382 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 3 of its ownK251217 SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025
- Descendant · 2 generations on · 2 of its ownK243823 Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · Recalled
- Descendant · cites it directly · 2 of its ownK220916 iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK203689 Tidepool LoopTidepool Project · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K232382Control-IQ TechnologyTandem Diabetes Care, Inc. · 2023 · cites it directly7descendants
- K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025 · 2 generations on3descendants
- K243823Control-IQ+ technologyTandem Diabetes Care, Inc. · 2025 · 2 generations on2descendants
- K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023 · cites it directly2descendants
- K203689Tidepool LoopTidepool Project · 2023 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| 0 (this device) | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| +1 | K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023 | 1 |
| +2 | K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025 | — |
| +2 | K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025 | 1 |
| +1 | K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023 | — |
| +1 | K203689 | Tidepool Loop | Tidepool Project | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
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 |
|---|---|---|---|
| * | DEN190034 | Control-IQ TechnologySummary page 4…trol-IQ technology Regulation Name/Number Interoperable automated glycemic controller per 21 CFR 862.1356 Product Codes QJI Predicate Device Control-IQ technology (DEN190034) Device Description The Control-IQ technology, is an interoperable automated glycemic controller. This is a device intended to… | 2019 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 6 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/K200467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200467: Control-IQ Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200467
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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