FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System— 510(k) K233537
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K233537 for FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System, Substantially Equivalent on 2024-04-23. Applicant: Abbott Diabetes Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code QBJ
- 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 QBJ
view all- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System
- K240902 — Dexcom G7 Continuous Glucose Monitoring System
More clearances from Abbott Diabetes Care, Inc.
view all- 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
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
- K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System
Adverse events under product code QBJ
product code QBJ- Death
- 180
- Injury
- 31,825
- Malfunction
- 1,792,244
- Other
- 36
- Total
- 1,824,285
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 K233537
K-number listed on FDA's recall record- Z-1021-2026 — FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
- Z-1022-2026 — FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a 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 K233537.
Data sourced from openFDA. This site is unofficial and independent of the FDA.