510(k) · Cleared
ClearedDexcom G6 Glucose Program Continuous Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcom, Inc. · QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
Cleared on Oct 26, 2018 as substantially equivalent to DEN170088 (Dexcom, Inc., 2018) after an 88-day review. Its family tree reaches back 1 generation to 2018. 2 of the 24 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- Oct 26, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- QDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170088 (2018). 22 later devices descend from it, 1 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- This deviceK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- Descendant · cites it directly · 21 of its ownK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 17 of its ownK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 15 of its ownK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- Descendant · 4 generations on · 12 of its ownK213919 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · Recalled (Class I)
- Descendant · 5 generations on · 11 of its ownK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc. · 2019 · cites it directly21descendants
- K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Dexcom, Inc. · 2020 · 2 generations on17descendants
- K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021 · 3 generations on15descendants
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 4 generations on12descendants
- K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| 0 (this device) | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| +1 | 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 |
| +3 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| +4 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 | Class I |
| +5 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 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 QDK device
- #1 K203089 Dexcom G6 Glucose Program Continuous Glucose…score 5.8 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | DEN170088 | Dexcom G6 Continuous Glucose Monitoring SystemSummary page 4…2.1355 Product Code QDK Review Panel Clinical Chemistry C. Predicate Device: Dexcom G6 Continuous Glucose Monitoring System (DEN170088) D. Device Description: The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose… | 2018 |
| † | DEN140016 | Continuous Glucose Monitor Retrospective Data Analysis Software |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous… | 2019 | 21 |
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.
- K213919Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
- K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All QDK devicesQDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDK
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QDK
Too few QDK 510(k)s in any year since 2007 to give a median.
Recalls per year · QDK
No recall names QDK since 2007.
Adverse event reports per year · QDK
63in 2025
MAUDE reports naming product code QDK, 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 | 0 |
| 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 | 2 |
| 2019 | 1 | — | 0 | 26 |
| 2020 | 1 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 111 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 0 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 238 |
| 2025 | 0 | — | 0 | 63 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 age 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…
Read the full statement (146 words)
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 age 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182041: Dexcom G6 Glucose Program Continuous 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/K182041
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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