FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537)
Description
FreeStyle Libre 2 System, FreeStyle Libre 3 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 K223537
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 System, FreeStyle Libre 3 System (K223537) cites 3 predicate devices and is itself cited by 0 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 |
Trace the full predicate network for K223537
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.