# K193371: FreeStyle Libre 2 Flash Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Jun 12, 2020 after 190 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 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170088 (2018). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170088: Dexcom G6 Continuous Glucose Monitoring System, Dexcom, Inc. (2018) Summary page 4.

## Most influential descendants
- K201761: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (2021), 9 descendants of its own
- K210943: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (2021), 7 descendants of its own
- K222447: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (2023), 4 descendants of its own
- K223435: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (2023), 1 descendant of its own
- K212132: FreeStyle Libre 3 Continuous Glucose Monitoring System (2022), 1 descendant of its own

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2414-2023: If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If use
- Feb 13, 2023 · Class I · Z-1275-2023: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged
- Mar 16, 2021 · Class II · Z-1931-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

## Indications for use
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time 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/K193371
Methodology: https://510kreport.com/methodology