FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447)
Description
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System by Abbott Diabetes Care, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222447
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447) cites 3 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022 |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022 |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with Fre... | Abbott Diabetes Care, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Diabetes Care | 2024 |
| K233655 | Lingo Glucose System | Abbott | 2024 |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; Fre... | Abbott Diabetes Care, Inc. | 2023 |
Trace the full predicate network for K222447
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.