SmartGuard technology; Predictive Low Glucose technology
Summary
Medtronic Minimed, Inc. received 510(k) clearance for SmartGuard technology; Predictive Low Glucose technology, a QJI device. Cleared on 2025-08-29.
Details
Source
510(k) Clearance
External ID
K251217
Action Date
2025-08-29
Status
Traditional
Category
device
Product Code
QJI
Product Description
SmartGuard technology; Predictive Low Glucose technology. Product code: QJI.
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. Medtronic Minimed, Inc. has received 6 total clearances in our database.
Medtronic Minimed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 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 Medtronic Minimed, Inc. have FDA actions?
Medtronic Minimed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251217" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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