Bigfoot Unity Diabetes Management System
FDA 510(k) clearance K202145 · decided 2021-05-07
Clearance details
- K-number
- K202145
- Device name
- Bigfoot Unity Diabetes Management System
- Applicant
- Bigfoot Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-31
- Decision date
- 2021-05-07
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- QLG
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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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 (K212132) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| 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 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K193371) | Abbott Diabetes Care, Inc. | 2020-06-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmw recall (Z-1997-2025) | BIGFOOT BIOMEDICAL | 2025-06-20 |