De Novo · Granted
GrantedDexcom G6 Continuous Glucose Monitoring 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
Granted on Mar 27, 2018 as a new device type through De Novo after a 109-day review. 5 of the 40 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it.
- Decided
- Mar 27, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- None
39 later devices descend from it, 4 citing it directly. 5 of the 40 devices in this family, counting this one, have a Class I recall.
- This deviceDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- Descendant · cites it directly · 22 of its ownK183206 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2019
- Descendant · cites it directly · 22 of its ownK182405 Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- Descendant · cites it directly · 22 of its ownK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- Descendant · 2 generations on · 21 of its ownK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 17 of its ownK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193371 FreeStyle Libre 2 Flash Glucose Monitoring Systemcites it directly · 2020
- K212132 FreeStyle Libre 3 Continuous Glucose Monitoring…3 generations on · 2022
- K213919 Dexcom G7 Continuous Glucose Monitoring System5 generations on · 2022
- K223931 Dexcom G6 Continuous Glucose Monitoring (CGM)…5 generations on · 2023
Most influential descendants
Showing 5 of 39 · See all- K183206Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2019 · cites it directly22descendants
- K182405Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. · 2018 · cites it directly22descendants
- K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018 · cites it directly22descendants
- K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc. · 2019 · 2 generations on21descendants
- K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc. · 2020 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| +1 | K183206 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2019 | — |
| +1 | K182405 | Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| +1 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 1 |
| 2021 | 6 | 0 |
| 2022 | 4 | 2 |
| 2023 | 6 | 1 |
| 2024 | 6 | 1 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
Sources: FDA De Novo 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.
5 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (39)
See all 394 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 13 Class I recalls
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
- K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K183206 (Dexcom, Inc., 2019) has gone furthest, with 22 descendants of its own.
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. 2018, 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/DEN170088 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170088: Dexcom G6 Continuous Glucose Monitoring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170088
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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