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.
Clearance details
- Applicant
- Medtronic MiniMed
- Product code
- 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.