SmartGuard Technology; Predictive Low Glucose Technology— 510(k) K253701
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K253701 for SmartGuard Technology; Predictive Low Glucose Technology, Substantially Equivalent on 2026-02-03. Applicant: Medtronic Minimed. Device class: 2.
Summary
Medtronic MiniMed lists SmartGuard Technology and Predictive Low Glucose Technology under product code QJI, interoperable automated glycemic controller. 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 Traditional 510(k).
Medtronic MiniMed filed from Northridge, California. The substantially equivalent decision came 71 calendar days after receipt (November 24, 2025 to February 3, 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
- Traditional
- 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.