K253585
- 510(k) number
- K253585
- Device name
- SmartGuard technology; Predictive Low Glucose technology
- Applicant
- Medtronic Minimed, Inc. CA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2026-01-14
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253585.pdf
Official FDA record: K253585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.