FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
FDA 510(k) K223435 · Abbott Diabetes Care, Inc.
Submission
- Device name
- FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- Applicant
- Abbott Diabetes Care, Inc.
Alameda, CA, US - Received
- November 14, 2022
- Decision date
- April 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Specialty
- Clinical Chemistry
An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with…
Other 510(k)s with product code QBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional | Dexcom, Inc. | 06/08/2026SE |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional | Dexcom, Inc. | 02/03/2026SE |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special | Dexcom, Inc. | 12/17/2025SE |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional | Dexcom, Inc. | 04/09/2025SE |
| K240902 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special | Dexcom, Inc. | 04/23/2024SE |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | Abbott Diabetes Care, Inc. | 04/23/2024SE |
| K234133 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional | Dexcom, Inc. | 02/26/2024SE |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) SystemQBJ · Special | Dexcom, Inc. | 05/15/2023SE |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…QBJ · Traditional | Abbott Diabetes Care, Inc. | 03/03/2023SE |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ · Special | Dexcom, Inc. | 01/11/2023SE |
More from Dexcom, 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 |
| 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 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)QLG · Traditional | 11/22/2021SE |
| 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 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System cleared by the FDA?
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K223435) received a 510(k) decision of Substantially Equivalent on April 13, 2023, 150 days after the submission was received.
What is the product code of K223435?
The FDA product code is QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated, a Class II (moderate risk) device regulated under 21 CFR 862.1355.