510(k) · Cleared
ClearedSmartGuard technology; Predictive Low Glucose technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed, Inc. · QJI Interoperable Automated Glycemic Controller
Cleared on Jan 14, 2026 as substantially equivalent to K251217 (Medtronic Minimed, Inc., 2025) after a 58-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Jan 14, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN190034 (2019). No later device cites it as a predicate yet.
- 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 backK251217 SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025
- This deviceK253585 SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2026
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 | K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025 | — |
| 0 (this device) | K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, 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 |
|---|---|---|---|
| * | K251217 | SmartGuard technology; Predictive Low Glucose technologySummary page 6…evice Class Class II Predicate Device Information Product Code Predicate Device QJI SmartGuard technology (K251217) QJS Predictive Low Glucose technology (K251217)… | 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 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K251217.
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?
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values. SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older…
Read the full statement (193 words)
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values.
SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.
SmartGuard technology is intended for single patient use and requires a prescription.
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.
Predictive Low Glucose technology is intended for single patient use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253585: SmartGuard technology; Predictive Low Glucose technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253585
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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