K261962
- 510(k) number
- K261962
- Device name
- SmartGuard Technology; Predictive Low Glucose Technology
- Applicant
- Medtronic MiniMed CA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2026-07-09
- Date received
- 2026-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K261962.pdf
Official FDA record: K261962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.