510(k) · Cleared
Recalled · Class I · 2025FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle 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. · QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Cleared on Apr 23, 2024 as substantially equivalent to K223435 (Abbott Diabetes Care, Inc., 2023) after a 172-day review. Its family tree reaches back 6 generations to 2018. 2 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Apr 23, 2024
- Review
- 172 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN170088 (2018). 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 · 6 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 5 generations backK193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 4 generations backK201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 3 generations backK210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle…Abbott Diabetes Care, Inc. · 2021
- 2 generations backK222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3…Abbott Diabetes Care, Inc. · 2023
- 1 generation backK223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle…Abbott Diabetes Care, Inc. · 2023
- This deviceK233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle…Abbott Diabetes Care, Inc. · 2024
Class I recalls in this family
- K193371 FreeStyle Libre 2 Flash Glucose Monitoring System5 generations back · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −5 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020 | Class I |
| −4 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| −3 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Abbott Diabetes Care, Inc. | 2021 | — |
| −2 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3… | Abbott Diabetes Care, Inc. | 2023 | — |
| −1 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2… | Abbott Diabetes Care, Inc. | 2023 | — |
| 0 (this device) | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2… | Abbott Diabetes Care, Inc. | 2024 | — |
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 QBJ device
- #1 K253737 Dexcom G7 Continuous Glucose Monitoring (CGM)…score 16.5 · 10 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 |
|---|---|---|---|
| * | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Summary page 6…Freestyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System (K223435) 510(k) Summary, Page 1 of 19… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2025 | Class I | Z-1022-2026 | Process control | 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-1021-2026 | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose 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.
- K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All QBJ devicesQBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QBJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QBJ
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBJ
4so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · QBJ
374,651in 2025
MAUDE reports naming product code QBJ, 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 | 3 |
| 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 | 1 | — | 0 | 37,106 |
| 2019 | 2 | — | 0 | 80,774 |
| 2020 | 1 | — | 0 | 200,738 |
| 2021 | 1 | — | 0 | 254,833 |
| 2022 | 2 | — | 0 | 232,288 |
| 2023 | 4 | 89 | 0 | 273,565 |
| 2024 | 3 | 59 | 0 | 347,124 |
| 2025 | 2 | — | 2 (1) | 374,651 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
Libre 2 Sensor users: 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…
Read the full statement (528 words)
Libre 2 Sensor users:
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.
Libre 2 Plus Sensor users:
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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Libre 3 Sensor users:
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.
Libre 3 Plus Sensor users:
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 2 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, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233537: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233537
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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