SmartGuard technology; Predictive Low Glucose technology— 510(k) K251217
Substantially EquivalentMedtronic Minimed, Inc.
FDA 510(k) clearance K251217 for SmartGuard technology; Predictive Low Glucose technology, Substantially Equivalent on 2025-08-29. Applicant: Medtronic Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed, Inc.
- 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
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code QJI
view allMore clearances from Medtronic Minimed, Inc.
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.