Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Summary
Abbott Diabetes Care received 510(k) clearance for Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, a SJD device. Cleared on 2026-08-25.
Details
Source
510(k) Clearance
External ID
DEN250049
Action Date
2026-08-25
Status
Direct
Category
device
Product Code
SJD
Product Description
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System. Product code: SJD.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. Abbott Diabetes Care has received 2 total clearances in our database.
Abbott Diabetes Care has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Abbott Diabetes Care have FDA actions?
Abbott Diabetes Care has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN250049" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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