510(k) · Cleared
ClearedFreeStyle 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 13, 2023 as substantially equivalent to K222447 (Abbott Diabetes Care, Inc., 2023) after a 150-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. 1 later device descends from it.
- Decided
- Apr 13, 2023
- Review
- 150 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170088 (2018). 1 later device descends from it, 1 citing it directly. 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 backK222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3…Abbott Diabetes Care, Inc. · 2023
- This deviceK223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle…Abbott Diabetes Care, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle…Abbott Diabetes Care, Inc. · 2024 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…Abbott Diabetes Care, Inc. · 2024 · cites it directly0descendants
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 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3… | Abbott Diabetes Care, Inc. | 2023 | — |
| 0 (this device) | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2… | Abbott Diabetes Care, Inc. | 2023 | — |
| +1 | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2… | Abbott Diabetes Care, Inc. | 2024 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose… Cleared while this submission was under review Summary page 5…Freestyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System (K222447) 510(k) Summary, Page 1 of 15… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose… Class I | 2024 | 0 |
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.
- K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K233537 (Abbott Diabetes Care, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K222447.
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. 2023, 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?
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…
Read the full statement (258 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 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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223435: 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 4, 2026. https://510kreport.com/device/K223435
Report an extraction error
Are you the manufacturer?
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