510(k) · Cleared
Recalled · Class I · 2025Dexcom G6 Continuous Glucose Monitoring (CGM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcom, Inc. · QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Cleared on Jan 11, 2023 as substantially equivalent to K221259 (Dexcom, Inc., 2022) after a 12-day review. Its family tree reaches back 6 generations to 2018. 1 of the 11 devices in its family, counting itself, has a Class I recall. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Jan 11, 2023
- Review
- 12 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- 5 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN170088 (2018). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 5 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 4 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 3 generations backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- 2 generations backK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- 1 generation backK221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6…Dexcom, Inc. · 2022
- This deviceK223931 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023
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 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −4 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | 2 |
| −3 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| −2 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| −1 | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose… | Dexcom, Inc. | 2022 | — |
| 0 (this device) | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
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.
1 device in this family has 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 |
|---|---|---|---|
| * | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program…Summary page 4…inical Chemistry 7.3. Predicate and Reference Devices Predicate Device Dexcom G6 Continuous Glucose Monitoring (CGM) System (K221259, cleared July 29, 2022) Reference Devices Dexcom G6 Continuous Glucose Monitoring (CGM)… | 2022 |
| † | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | 2018 |
| † | K213919 | Dexcom G7 Continuous Glucose Monitoring System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-0318-2026 | Software Design Change | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed… |
| May 12, 2025 | Class I | Z-1943-2025 | Nonconforming Material/Component | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose… |
| Jan 27, 2025 | Class II | Z-1203-2025 | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an… |
| Jan 27, 2025 | Class II | Z-1202-2025 | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an… |
| Jan 27, 2025 | Class II | Z-1204-2025 | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 2 of the 10 ancestors have a recall of any class.
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 Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System…
Read the full statement (132 words)
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223931: Dexcom G6 Continuous Glucose Monitoring (CGM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223931
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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