510(k) · Cleared
Recalled · Class I · 2023FreeStyle Libre 2 Flash Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Cleared on Jun 12, 2020 as substantially equivalent to DEN170088 (Dexcom, Inc., 2018) after a 190-day review. Its family tree reaches back 1 generation to 2018. 3 of the 15 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jun 12, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- QLG
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170088 (2018). 13 later devices descend from it, 3 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- This deviceK193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020
- Descendant · cites it directly · 9 of its ownK201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- Descendant · 2 generations on · 7 of its ownK210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3…Abbott Diabetes Care, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle…Abbott Diabetes Care, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK212132 FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2022 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. · 2021 · cites it directly9descendants
- K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc. · 2021 · 2 generations on7descendants
- K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…Abbott Diabetes Care, Inc. · 2023 · 3 generations on4descendants
- K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc. · 2023 · 4 generations on1descendant
- K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| 0 (this device) | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020 | — |
| +1 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| +2 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| +3 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3… | Abbott Diabetes Care, Inc. | 2023 | — |
| +4 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2… | Abbott Diabetes Care, Inc. | 2023 | — |
| +2 | K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2022 | 2 | 1 |
| 2023 | 4 | 0 |
| 2024 | 3 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLG device
- #1 K210943 FreeStyle Libre 2 Flash Glucose Monitoring…score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170088 | Dexcom G6 Continuous Glucose Monitoring SystemSummary page 4…e(s): QLG, NBW Review Panel: Clinical Chemistry 1.3 Predicate Device Predicate Device: Dexcom G6 Continuous Glucose Monitoring System, DEN170088 510(k) Summary, Page 1 of 31… | 2018 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2023 | Class II | Z-2414-2023 | Software Design Change | 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 users don't have the previous sensor, or… |
| Feb 13, 2023 | Class I | Z-1275-2023 | Device Design | 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, cracked, swelling, too hot to hold… |
| Mar 16, 2021 | Class II | Z-1931-2021 | Environmental control | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 13 Class I recalls
- K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All QLG devicesQLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QLG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QLG
259in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QLG
4in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · QLG
20,199in 2025
MAUDE reports naming product code QLG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1,069 |
| 2021 | 4 | 259 | 0 | 22,500 |
| 2022 | 2 | — | 0 | 26,528 |
| 2023 | 2 | — | 1 | 39,321 |
| 2024 | 0 | — | 0 | 35,108 |
| 2025 | 0 | — | 4 (4) | 20,199 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (126 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193371: FreeStyle Libre 2 Flash Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193371
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026