FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
FDA 510(k) K210943 · Abbott Diabetes Care, Inc.
Submission
- Device name
- FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- Applicant
- Abbott Diabetes Care, Inc.
Alameda, CA, US - Received
- March 30, 2021
- Decision date
- November 22, 2021
- 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 |
|---|---|---|---|
| K222280 | Bigfoot Unity® Diabetes Management SystemQLG · Traditional | Bigfoot Biomedical, Inc. | 03/01/2023SE |
| 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 |
| 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 |
|---|---|---|
| K233861 | Libre Rio Continuous Glucose Monitoring SystemSBH · Traditional | 06/07/2024SE |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | 04/23/2024SE |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | 04/13/2023SE |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…QBJ · Traditional | 03/03/2023SE |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 SystemQLG · Traditional | 02/21/2023SE |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | 05/26/2022SE |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemQLG · Traditional | 05/26/2022SE |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG · Traditional | 08/11/2021SE |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | 07/30/2021SE |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring SystemQLG · Traditional | 06/12/2020SE |
Questions and answers
When was FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) cleared by the FDA?
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) received a 510(k) decision of Substantially Equivalent on November 22, 2021, 237 days after the submission was received.
What is the product code of K210943?
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.