FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dexcom Smart Basal
K Number: K252818
·
Decision Nov 18, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
27
Review Days
75
Basic Information
- Device Name
- Dexcom Smart Basal
- K Number
- K252818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1358
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dexcom, Inc.
- Date Received
- September 4, 2025
- Decision Date
- November 18, 2025
- Product Code
- QRX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K261359 | Stelo Glucose Biosensor System | May 21, 2026 | Substantially Equivalent |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Feb 3, 2026 | Substantially Equivalent |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dec 17, 2025 | Substantially Equivalent |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Apr 9, 2025 | Substantially Equivalent |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | Apr 23, 2024 | Substantially Equivalent |
| K234070 | Stelo Glucose Biosensor System | Mar 5, 2024 | Substantially Equivalent |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Feb 26, 2024 | Substantially Equivalent |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | May 15, 2023 | Substantially Equivalent |