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 · QJI Interoperable Automated Glycemic Controller
Cleared on Jul 9, 2026 as substantially equivalent to K253701 (Medtronic Minimed, 2026) after a 28-day review. Its family tree reaches back 13 generations to 2001. 3 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 9, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K010362 (2001). 29 ancestors in all. No later device cites it as a predicate yet. 3 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 9 generations between
- 3 generations backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- 2 generations backK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- 1 generation backK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- This deviceK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
Show all 13 generations
- Root · 13 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 12 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 11 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 10 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 9 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 8 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 7 generations backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- 6 generations backK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- 5 generations backK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- 4 generations backK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- 3 generations backK242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 2024 · Recalled
- 2 generations backK251032 MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 2025 · Recalled
- 1 generation backK253701 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
- This deviceK261962 SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −12 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −11 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −10 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −9 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −8 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −7 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| −6 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| −5 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| −4 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| −3 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | 2024 | 3 |
| −2 | K251032 | MiniMed 780G insulin pump | Medtronic Minimed, Inc. | 2025 | 6 |
| −1 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026 | — |
| 0 (this device) | K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 1 |
| 2022 | 1 | 1 |
| 2023 | 2 | 1 |
| 2025 | 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.
3 devices in this family have 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
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 |
|---|---|---|---|
| * | K253701 | SmartGuard Technology; Predictive Low Glucose TechnologySummary page 5…Interoperable Automated Glycemic Controller Name Regulation Number 21 CFR 862.1356 Product Codes QJI, QJS, NDC Predicate Device K253701- SmartGuard Technology and Predictive Low Glucose Technology Device Panel Clinical… | 2026 |
| † | K253585 | SmartGuard technology; Predictive Low Glucose technology | 2026 |
| † | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2023 · 3 generations back · ◆ in the 2023 ancestors bar of FIG. 11 Class I recall
- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. · 2022 · 4 generations back · ◆ in the 2022 ancestors bar of FIG. 11 Class I recall
- K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. · 2020 · 5 generations back · ◆ in the 2020 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
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: SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values. SmartGuard technology is intended for the management of Type…
Read the full statement (232 words)
SmartGuard Technology:
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.
SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and 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:
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.
Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.
Predictive Low Glucose technology is intended for the management of type 1 diabetes mellitus in persons 7 years of age and older, and 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/K261962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261962: SmartGuard Technology; Predictive Low Glucose Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261962
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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