FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stelo Glucose Biosensor System
K Number: K234070
·
Decision Mar 5, 2024
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
3
Applicant Total
27
Review Days
74
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Basic Information
- Device Name
- Stelo Glucose Biosensor System
- K Number
- K234070
- 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 22, 2023
- Decision Date
- March 5, 2024
- Product Code
- SAF
- 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 |
|---|---|---|---|
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SAF), ordered by most recent decision date.
Stelo Glucose Biosensor System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Signos Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lingo Glucose 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 |
| 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 |