510(k) · Cleared
ClearedDexcom Pro Q Continuous Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexcom, Inc. · QDL Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Cleared on Nov 2, 2018 as substantially equivalent to DEN170088 (Dexcom, Inc., 2018) after a 59-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
- Nov 2, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- QDL
- 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 deviceK182405 Dexcom Pro Q 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) | K182405 | Dexcom Pro Q 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.
- 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 |
|---|---|---|---|
| * | DEN170088 | Dexcom G6 Continuous Glucose Monitoring SystemSummary page 6…ally connected devices. 5.6 COMPARISON WITH THE PREDICATE DEVICE: Device Dexcom Pro Q System (K182405) Dexcom G6 CGM System (DEN170088) Trade Name Dexcom Pro Q Continuous Glucose Dexcom G6 Continuous Glucose Monitoring S… | 2018 |
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 QDL devicesQDL Integrated Continuous Glucose Monitoring System For Professional Retrospective Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QDL
Too few QDL 510(k)s in any year since 2007 to give a median.
Recalls per year · QDL
No recall names QDL since 2007.
Adverse event reports per year · QDL
No MAUDE report names QDL since 2007.
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 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.…
Read the full statement (127 words)
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.
Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182405: Dexcom Pro Q 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/K182405
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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