510(k) · Cleared
ClearedDexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) 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 Aug 17, 2021 as substantially equivalent to K200876 (Dexcom, Inc., 2020) after a 308-day review. Its family tree reaches back 4 generations to 2018. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Aug 17, 2021
- Review
- 308 days
- Class
- Class II
- Product code
- QDK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170088 (2018). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 3 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 2 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 1 generation backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- This deviceK203089 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6…Dexcom, Inc. · 2022
- Descendant · 2 generations on · 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)…2 generations on · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −3 | 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 |
| −1 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| 0 (this device) | K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| +1 | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose… | Dexcom, Inc. | 2022 | — |
| +2 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 QDK device
- #1 K193642 Dexcom G6 Glucose Program Continuous Glucose…score -0.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous… Cleared while this submission was under review Summary page 5…QDK Review Panel Clinical Chemistry 5.3 PREDICATE DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K200876) 5.4 DEVICE DESCRIPTION: The Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System measures and displays glucose… | 2020 |
| † | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program… | 2022 | 1 |
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 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K221259 (Dexcom, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K200876.
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. 2021, 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 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…
Read the full statement (144 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203089: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203089
Report an extraction error
Are you the manufacturer?
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