510(k) K252818
K252818 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Dexcom Smart Basal". The FDA issued a decision of Substantially Equivalent on November 18, 2025. The device falls under product code QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator), a Class II device regulated under 21 CFR 862.1358. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2025
- Date Received
- September 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Glucose Monitor Informed Insulin Dose Calculator
- Device Class
- Class II
- Regulation Number
- 862.1358
- Review Panel
- CH
- Submission Type
A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.