De Novo · Granted
GrantedLibre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care · SJD Integrated Continuous Glucose Ketone Monitoring System
Granted on Aug 25, 2026 as a new device type through De Novo after a 330-day review.
- Decided
- Aug 25, 2026
- Review
- 330 days
- Class
- Class II
- Product code
- SJD
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SJD? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SJD devicesSJD Integrated Continuous Glucose Ketone Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SJD
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SJD
Too few SJD 510(k)s in any year since 2007 to give a median.
Recalls per year · SJD
No recall names SJD since 2007.
Adverse event reports per year · SJD
No MAUDE report names SJD 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 | 0 | — | 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 | 1 | — | 0 | — |
What is it indicated for?
Libre Duo 10 Day is a Continuous Dual Glucose Ketone Monitoring System indicated for the management of diabetes in persons age 2 years and older. It is intended to monitor glucose and ketone (beta-hydroxybutyrate) levels in real-time. The System also provides alarms, detects trends, tracks glucose and ketone patterns, and aids in the detection of episodes of hyperglycemia, hypoglycemia, and hyperketonemia, facilitating both acute and long-term therapy…
Read the full statement (157 words)
Libre Duo 10 Day is a Continuous Dual Glucose Ketone Monitoring System indicated for the management of diabetes in persons age 2 years and older. It is intended to monitor glucose and ketone (beta-hydroxybutyrate) levels in real-time.
The System also provides alarms, detects trends, tracks glucose and ketone patterns, and aids in the detection of episodes of hyperglycemia, hypoglycemia, and hyperketonemia, facilitating both acute and long-term therapy adjustments, and the system replaces blood glucose testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of system readings should be based on the trends and sequential readings over time. When making therapeutic adjustments, ketone output should be used in conjunction with glucose levels, symptoms, and factors that may affect ketone levels such as eating patterns and exercise.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250049 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250049
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026