FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dexcom G7 Continuous Glucose Monitoring System
K Number: K234133
·
Decision Feb 26, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
17
Applicant Total
27
Review Days
59
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Basic Information
- Device Name
- Dexcom G7 Continuous Glucose Monitoring System
- K Number
- K234133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dexcom, Inc.
- Date Received
- December 29, 2023
- Decision Date
- February 26, 2024
- Product Code
- QBJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBJ), ordered by most recent decision date.
Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
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Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
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FDA Class 2
·Clinical Chemistry
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dexcom G7 Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Dexcom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260935 | Stelo Glucose Biosensor System | Jun 12, 2026 | Substantially Equivalent |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Jun 8, 2026 | Substantially Equivalent |
| 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 |
| K252818 | Dexcom Smart Basal | Nov 18, 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 |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | May 15, 2023 | Substantially Equivalent |