SmartGuard technology; Predictive Low Glucose technology— 510(k) K253585

Substantially Equivalent

Medtronic Minimed, Inc.

FDA 510(k) clearance K253585 for SmartGuard technology; Predictive Low Glucose technology, Substantially Equivalent on 2026-01-14. Applicant: Medtronic Minimed, Inc..

Clearance details

Applicant: Medtronic Minimed, Inc.
Product code: Code QJI
Advisory panel: Clinical Chemistry
Date received: 2025-11-17
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.