FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
K Number: K223435
·
Decision Apr 13, 2023
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
17
Applicant Total
37
Review Days
150
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K Number
- K223435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Diabetes Care, Inc.
- Date Received
- November 14, 2022
- Decision Date
- April 13, 2023
- Product Code
- QBJ
- 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 |
|---|---|---|---|
| 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
·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 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 Abbott Diabetes Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Apr 23, 2024 | Substantially Equivalent |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | Mar 3, 2023 | Substantially Equivalent |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Feb 21, 2023 | Substantially Equivalent |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 | Substantially Equivalent |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 | Substantially Equivalent |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Nov 22, 2021 | Substantially Equivalent |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Aug 11, 2021 | Substantially Equivalent |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Jul 30, 2021 | Substantially Equivalent |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Jun 12, 2020 | Substantially Equivalent |
| K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | Sep 27, 2017 | Substantially Equivalent |