QLG
9 FDA 510(k) clearances · Product code
215 daysmedian time to decision
396 days90th percentile
9clearances measured
FDA profile
- Official device name
- 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
- Medical specialty
- Clinical Chemistry
- FDA 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.
- Adverse events (MAUDE)
- 2021: 22,500 · 2022: 26,528 · 2023: 39,322 · 2024: 35,112 · 2025: 20,527 · 2026: 20,410
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| Bigfoot Unity Diabetes Management System (K202145) | Bigfoot Biomedical, Inc. | 2021-05-07 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K193371) | Abbott Diabetes Care, Inc. | 2020-06-12 |
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Every clearance here is in the API, with alerts when new ones post.