FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
FDA 510(k) clearance K233537 · decided 2024-04-23
Clearance details
- K-number
- K233537
- Device name
- FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-03
- Decision date
- 2024-04-23
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- QBJ
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Diabetes Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre recall (Z-1021-2026) | Abbott Diabetes Care, Inc. | 2026-01-14 |
| FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre recall (Z-1022-2026) | Abbott Diabetes Care, Inc. | 2026-01-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S057) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S060) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S056) | Abbott Diabetes Care, Inc. | 2024-04-05 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S059) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S055) | Abbott Diabetes Care, Inc. | 2023-11-21 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S058) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S053) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S052) | Abbott Diabetes Care, Inc. | 2023-01-17 |