FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA 510(k) clearance K212132 · decided 2022-05-26
Clearance details
- K-number
- K212132
- Device name
- FreeStyle Libre 3 Continuous Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-08
- Decision date
- 2022-05-26
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- QLG
- 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
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
| Record | Firm | Date |
|---|---|---|
| Bigfoot Unity® Diabetes Management System (K222280) | Bigfoot Biomedical, Inc. | 2023-03-01 |
| FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537) | Abbott Diabetes Care, Inc. | 2023-02-21 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) | Abbott Diabetes Care, Inc. | 2021-11-22 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K211102) | Abbott Diabetes Care, Inc. | 2021-08-11 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761) | Abbott Diabetes Care, Inc. | 2021-07-30 |
| Bigfoot Unity Diabetes Management System (K202145) | Bigfoot Biomedical, Inc. | 2021-05-07 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K193371) | Abbott Diabetes Care, Inc. | 2020-06-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 se recall (Z-1020-2026) | Abbott Diabetes Care, Inc. | 2026-01-14 |
| FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre recall (Z-1023-2026) | Abbott Diabetes Care, Inc. | 2026-01-14 |
| FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Gl recall (Z-2692-2024) | Abbott Diabetes Care, Inc. | 2024-08-27 |
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 |