510(k) · Cleared
Recalled · Class II · 2026Dexcom G7 15 Day 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 Apr 9, 2025 as substantially equivalent to K240902 (Dexcom, Inc., 2024) after a 188-day review. Its family tree reaches back 9 generations to 2018. 1 of the 15 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 9, 2025
- Review
- 188 days
- Class
- Class II
- Product code
- QBJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN170088 (2018). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 5 generations between
- 3 generations backK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
- 2 generations backK234133 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024
- 1 generation backK240902 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024 · Recalled
- This deviceK243214 Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK253737 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15…Dexcom, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261402 Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day…Dexcom, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253710 Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15…Dexcom, Inc. · 2025
Show all 9 generations
- Root · 9 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 8 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 7 generations backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- 6 generations backK200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2020 · Recalled
- 5 generations backK201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2021
- 4 generations backK213919 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2022 · Recalled (Class I)
- 3 generations backK231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. · 2023 · Recalled
- 2 generations backK234133 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024
- 1 generation backK240902 Dexcom G7 Continuous Glucose Monitoring SystemDexcom, Inc. · 2024 · Recalled
- This deviceK243214 Dexcom G7 15 Day Continuous Glucose Monitoring SystemDexcom, Inc. · 2025
Class I recalls in this family
- K213919 Dexcom G7 Continuous Glucose Monitoring System4 generations back · 2022
Most influential descendants
Showing 3 of 3 · See all- K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…Dexcom, Inc. · 2026 · cites it directly1descendant
- K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…Dexcom, Inc. · 2026 · 2 generations on0descendants
- K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…Dexcom, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −8 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −7 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2019 | 2 |
| −6 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program… | Dexcom, Inc. | 2020 | 1 |
| −5 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2021 | — |
| −4 | K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 | Class I |
| −3 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 2023 | 1 |
| −2 | K234133 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024 | — |
| −1 | K240902 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2024 | 3 |
| 0 (this device) | K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | 2025 | — |
| +1 | K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day… | Dexcom, Inc. | 2026 | — |
| +2 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous… | Dexcom, Inc. | 2026 | — |
| +1 | K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day… | Dexcom, Inc. | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
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 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? (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 |
|---|---|---|---|
| * | K240902 | Dexcom G7 Continuous Glucose Monitoring SystemSummary page 5…Calibrated Regulation Number 862.1355 Product Code(s) QBJ, KGX LEGALLY MARKETED PREDICATE DEVICES Predicate # K240902 Predicate Trade Name Dexcom G7 Continuous Glucose Monitoring System Product Code QBJ === Page… | 2024 |
| † | K234070 | Stelo Glucose Biosensor System | 2024 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 14, 2026 | Class II | Z-2164-2026 | Software design | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue… |
| Apr 14, 2026 | Class II | Z-2163-2026 | Software design | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue… |
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 back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 5 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253737 (Dexcom, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K240902.
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. 2025, 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 G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older. The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several…
Read the full statement (156 words)
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older.
The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM 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/K243214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243214: Dexcom G7 15 Day 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/K243214
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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