510(k) · Cleared
ClearedFreeStyle Libre 2 System, FreeStyle Libre 3 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 Feb 21, 2023 as substantially equivalent to K210943 (Abbott Diabetes Care, Inc., 2021) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 2018. 2 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 21, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- QLG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to DEN170088 (2018). 6 ancestors in all. No later device cites it as a predicate yet. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 4 generations backK193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 3 generations backK201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 2 generations backK210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 1 generation backK213996 FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2022 · Recalled
- This deviceK223537 FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −4 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020 | Class I |
| −3 | 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 | — |
| −1 | K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2022 | 1 |
| 0 (this device) | K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Diabetes Care, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Summary page 5…3 Predicate Device Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), K210943 cleared November 22, 2021 FreeStyle Libre 3 Continuous Glucose Monitoring System, K213996… | 2021 |
| * | K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemSummary page 5…FreeStyle Libre 2 App), K210943 cleared November 22, 2021 FreeStyle Libre 3 Continuous Glucose Monitoring System, K213996 and K212132 cleared May 26, 2022 510(k) Summary… | 2022 |
| * | K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring SystemSummary page 5…210943 cleared November 22, 2021 FreeStyle Libre 3 Continuous Glucose Monitoring System, K213996 and K212132 cleared May 26, 2022 510(k) Summary Page 1 of 14 ===… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ in the 2022 ancestors bar of FIG. 13 Class I recalls
- K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K210943.
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. 2023, 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 (252 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223537: FreeStyle Libre 2 System, FreeStyle Libre 3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223537
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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