Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
Summary
Dexcom, Inc. received 510(k) clearance for Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System, a QBJ device. Cleared on 2025-12-17.
Details
Source
510(k) Clearance
External ID
K253710
Action Date
2025-12-17
Status
Special
Category
device
Product Code
QBJ
Product Description
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System. Product code: QBJ.
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 403 device clearances issued this month. Dexcom, Inc. has received 16 total clearances in our database.
Dexcom, Inc. has 33 FDA actions in our database, including 17 recalls and 16 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 Dexcom, Inc. have FDA actions?
Dexcom, Inc. has 33 FDA actions in our database, including 17 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253710" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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