510(k) · Cleared
ClearedDexcom G6 Pro Continuous Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcom, Inc. · QII Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
Cleared on Oct 7, 2019 as substantially equivalent to K191450 (Dexcom, Inc., 2019) after a 90-day review. Its family tree reaches back 3 generations to 2018. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 7, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- QII
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170088 (2018). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 2 generations backK182041 Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 1 generation backK191450 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose…Dexcom, Inc. · 2019 · Recalled
- This deviceK191833 Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc. · 2019
- 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 |
|---|---|---|---|---|---|
| −3 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −2 | 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 |
| 0 (this device) | K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System | Dexcom, Inc. | 2019 | — |
| +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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…Summary page 5…ode QII Review Panel Clinical Chemistry 5.3 PREDICATE DEVICE: Dexcom G6 Continuous Glucose Monitoring System (K191450) 5.4 DEVICE DESCRIPTION: 5.4.1 Dexcom G6 Pro Continuous Glucose Monitoring System The Dexcom G6 Pro Continuous Glu… | 2019 |
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 1 year and passes through 1 company; a new generation was cleared every 7 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K221259 (Dexcom, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K191450.
How does its category compare?
All QII devicesQII Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QII
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QII
Too few QII 510(k)s in any year since 2007 to give a median.
Recalls per year · QII
No recall names QII since 2007.
Adverse event reports per year · QII
2in 2025
MAUDE reports naming product code QII, 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 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 59 |
| 2023 | 0 | — | 0 | 62 |
| 2024 | 0 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System…
Read the full statement (195 words)
The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191833: Dexcom G6 Pro Continuous Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191833
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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