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 Jan 29, 2020 as substantially equivalent to K192787 (Dexcom, Inc., 2019) after a 30-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Jan 29, 2020
- Review
- 30 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. No later device cites it as a predicate yet.
- 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 backK192787 Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemDexcom, Inc. · 2019
- This deviceK193642 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2020
View 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 | K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | Dexcom, Inc. | 2019 | — |
| 0 (this device) | K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 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.
Planning a device in QDK? 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
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 |
|---|---|---|---|
| * | K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemSummary page 4…de QDK Review Panel Clinical Chemistry 1.3 PREDICATE DEVICE Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K192787, cleared October 25, 2019) 1.4 REFERENCE DEVICE Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K1… | 2019 |
| † | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 7 months on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2020, 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/K193642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193642: 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 6, 2026. https://510kreport.com/device/K193642
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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