K252818
- 510(k) number
- K252818
- Device name
- Dexcom Smart Basal
- Applicant
- Dexcom, Inc. CA · US
- Product code
- QRX — Continuous Glucose Monitor Informed Insulin Dose Cal
- Decision date
- 2025-11-18
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252818.pdf
Official FDA record: K252818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.