# K212132: FreeStyle Libre 3 Continuous Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: May 26, 2022 after 322 days
- Product code: QLG (Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170088 (2018). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201761: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), Abbott Diabetes Care, Inc. (2021). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K223537: FreeStyle Libre 2 System, FreeStyle Libre 3 System (2023), 0 descendants of its own

## Recalls of this device
- Nov 24, 2025 · Class I · Z-1023-2026: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Nov 24, 2025 · Class I · Z-1020-2026: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Jul 24, 2024 · Class I · Z-2692-2024: Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin

## Indications for use
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

Source page: https://510kreport.com/device/K212132
Methodology: https://510kreport.com/methodology