SmartGuard Technology; Predictive Low Glucose Technology— 510(k) K261962
Substantially EquivalentMedtronic MiniMed
FDA 510(k) clearance K261962 for SmartGuard Technology; Predictive Low Glucose Technology, Substantially Equivalent on 2026-07-09. Applicant: Medtronic MiniMed. Device class: 2.
Summary
Medtronic MiniMed's clearance covers SmartGuard Technology and Predictive Low Glucose Technology, filed under QJI, interoperable automated glycemic controllers. The record doesn't describe either one beyond its name and that code name.
Class II, 21 CFR 862.1356. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Special 510(k).
Medtronic MiniMed filed from Northridge, California. Review took 28 calendar days (June 11 to July 9, 2026).
Clearance details
- Applicant
- Medtronic MiniMed
- Product code
- Product code QJI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1356
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northridge, CA, US
Recent devices under product code QJI
view allMore clearances from Medtronic MiniMed
view allAdverse events under product code QJI
product code QJI- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.