FreeStyle Libre 3 Continuous Glucose Monitoring System— 510(k) K212132
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K212132 for FreeStyle Libre 3 Continuous Glucose Monitoring System, Substantially Equivalent on 2022-05-26. Applicant: Abbott Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code QLG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code QLG
view all- K222280 — Bigfoot Unity® Diabetes Management System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 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
More clearances from Abbott Diabetes Care, Inc.
view all- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
- K201761 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K193371 — FreeStyle Libre 2 Flash Glucose Monitoring System
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 →
Recalls naming K212132
K-number listed on FDA's recall record- Z-1020-2026 — 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.
- Z-1023-2026 — 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.
- Z-2692-2024 — FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212132.
Data sourced from openFDA. This site is unofficial and independent of the FDA.