510(k) K212132 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FreeStyle Libre 3 Continuous Glucose Monitoring System
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 26, 2022 |
| Received | Jul 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Sensor REF 72081-01
UDI-DI code: 00357599818005
The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | None listed |
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 72080-01
UDI-DI code: 00357599819002
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | None listed |
| Aug 27, 2024 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System Open, Classified |
QLG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.