Bigfoot Unity® Diabetes Management System
FDA 510(k) K222280 · Bigfoot Biomedical, Inc.
Submission
- Device name
- Bigfoot Unity® Diabetes Management System
- Applicant
- Bigfoot Biomedical, Inc.
Milpitas, CA, US - Received
- July 29, 2022
- Decision date
- March 1, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLG – Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Specialty
- Clinical Chemistry
An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data…
Other 510(k)s with product code QLG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 SystemQLG · Traditional | Abbott Diabetes Care, Inc. | 02/21/2023SE |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | Abbott Diabetes Care, Inc. | 05/26/2022SE |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | Abbott Diabetes Care, Inc. | 05/26/2022SE |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | Abbott Diabetes Care, Inc. | 11/22/2021SE |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG · Traditional | Abbott Diabetes Care, Inc. | 08/11/2021SE |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | Abbott Diabetes Care, Inc. | 07/30/2021SE |
| K202145 | Bigfoot Unity Diabetes Management SystemQLG · Traditional | Bigfoot Biomedical, Inc. | 05/07/2021SE |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG · Traditional | Abbott Diabetes Care, Inc. | 06/12/2020SE |
More from Abbott Diabetes Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202145 | Bigfoot Unity Diabetes Management SystemQLG · Traditional | 05/07/2021SE |
Questions and answers
When was Bigfoot Unity® Diabetes Management System cleared by the FDA?
Bigfoot Unity® Diabetes Management System (K222280) received a 510(k) decision of Substantially Equivalent on March 1, 2023, 215 days after the submission was received.
What is the product code of K222280?
The FDA product code is QLG – Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems, a Class II (moderate risk) device regulated under 21 CFR 862.1355.