Product code QLG— Clinical Chemistry
FreeStyle Libre 2 Flash Glucose Monitoring System
- Classification name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“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 to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.”
Market context for product code QLG
FDA has cleared devices under product code QLG between 2020 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2022
- 2021
- 2020
Top applicants under product code QLG
Adverse events under product code QLG
product code QLG- Death
- 27
- Injury
- 40,773
- Malfunction
- 107,857
- Other
- 6
- Total
- 148,663
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code QLG
- K222280 — Bigfoot Unity® Diabetes Management System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K202145 — Bigfoot Unity Diabetes Management System
- K193371 — FreeStyle Libre 2 Flash Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.