FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K Number: K203089
·
Decision Aug 17, 2021
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
27
Review Days
308
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Basic Information
- Device Name
- Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K Number
- K203089
- 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
- October 13, 2020
- Decision Date
- August 17, 2021
- Product Code
- QDK
- 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 |
|---|---|---|---|
| QDK | Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QDK), ordered by most recent decision date.
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dexcom G6 Glucose Program Continuous 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 |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | Feb 26, 2024 | Substantially Equivalent |