510(k) · Cleared
ClearedDexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional 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 Jul 29, 2022 as substantially equivalent to K201328 (Dexcom, Inc., 2021) and 2 other predicates after an 88-day review. Its family tree reaches back 5 generations to 2018. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 29, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to DEN170088 (2018). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 4 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 3 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 2 generations backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- 1 generation backK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- This deviceK221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6…Dexcom, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK223931 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled (Class I)
Class I recalls in this family
- K223931 Dexcom G6 Continuous Glucose Monitoring (CGM)…cites it directly · 2023
Most influential descendants
Showing 1 of 1 · See all- K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 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 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −3 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | 2 |
| −2 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| −1 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| 0 (this device) | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose… | Dexcom, Inc. | 2022 | — |
| +1 | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) SystemSummary page 7…uct Code QII Review Panel Clinical Chemistry 7.3. Predicate Device Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328, cleared July 15, 2021) Dexcom G6 Glucose Program CGM System (K203089, cleared August 17, 2021) Dexcom G6 Professional CGM System… | 2021 |
| * | K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemSummary page 7…emistry 7.3. Predicate Device Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328, cleared July 15, 2021) Dexcom G6 Glucose Program CGM System (K203089, cleared August 17, 2021) Dexcom G6 Professional CGM System (K191833, cleared October 7, 2019) 7.4. Device Description The prop… | 2021 |
| * | K191833 | Dexcom G6 Pro Continuous Glucose Monitoring SystemSummary page 7…ucose Monitoring (CGM) System (K201328, cleared July 15, 2021) Dexcom G6 Glucose Program CGM System (K203089, cleared August 17, 2021) Dexcom G6 Professional CGM System (K191833, cleared October 7, 2019) 7.4. Device Description The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and… | 2019 |
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 |
|---|---|---|---|
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Class I | 2023 | 0 |
Has anything in its family been recalled? (1 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.
- K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K223931 (Dexcom, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201328.
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. 2022, 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 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro…
Read the full statement (472 words)
The Dexcom G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
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/K221259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221259: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional 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/K221259
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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