510(k) · Cleared
Recalled · Class II · 2020Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q 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
Cleared on Jun 28, 2019 as substantially equivalent to K183206 (Dexcom, Inc., 2019) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 2018. 2 of the 26 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 28, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to DEN170088 (2018). 4 ancestors in all. 21 later devices descend from it, 3 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 1 generation backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- This deviceK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019
- Descendant · cites it directly · 17 of its ownK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 15 of its ownK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- Descendant · 3 generations on · 12 of its ownK213919 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · Recalled (Class I)
- Descendant · 4 generations on · 11 of its ownK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
- Descendant · 5 generations on · 5 of its ownK234133 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc. · 2020 · cites it directly17descendants
- K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021 · 2 generations on15descendants
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 3 generations on12descendants
- K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 4 generations on11descendants
- K234133Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −1 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| 0 (this device) | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | — |
| +1 | 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 | — |
| +3 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 | Class I |
| +4 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | 1 |
| +5 | K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 1 |
| 2023 | 2 | 1 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
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? (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 |
|---|---|---|---|
| * | K183206 | Dexcom G6 Continuous Glucose Monitoring SystemSummary page 7…assification Regulation 21 CFR 862.1355 Product Code QDL 6.3 PREDICATE DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206) Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) Dexcom Pro Q Continuous Glucose Monitorin… | 2019 |
| * | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemSummary page 7…L 6.3 PREDICATE DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206) Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) Dexcom Pro Q Continuous Glucose Monitoring System (K182405) 6.4 DEVICE DESCRIPTION: 6.4.1 Dexcom G6 Continuous… | 2018 |
| * | K182405 | Dexcom Pro Q Continuous Glucose Monitoring SystemSummary page 7…nitoring (CGM) System (K183206) Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) Dexcom Pro Q Continuous Glucose Monitoring System (K182405) 6.4 DEVICE DESCRIPTION: 6.4.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System The Dexcom G6 Cont… | 2018 |
| † | DEN140016 | Continuous Glucose Monitor Retrospective Data Analysis Software |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2020 | Class II | Z-1562-2020 | Under Investigation by firm | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. |
| Nov 19, 2019 | Class II | Z-1104-2020 | Software design | It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. |
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.
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
- K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200876 (Dexcom, Inc., 2020) has gone furthest, with 17 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. 2019, 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 (403 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.
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 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 Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.
Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191450
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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