MagnetOs MIS
Summary
Kuros Biosciences B.V received 510(k) clearance for MagnetOs MIS, a MQV device. Cleared on 2025-05-23.
Details
Source
510(k) Clearance
External ID
K243474
Action Date
2025-05-23
Status
Traditional
Category
device
Product Code
MQV
Product Description
MagnetOs MIS. Product code: MQV.
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. Kuros Biosciences B.V has received 8 total clearances in our database.
Kuros Biosciences B.V has 8 FDA actions in our database, including 8 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 Kuros Biosciences B.V have FDA actions?
Kuros Biosciences B.V has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243474" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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