MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
Summary
Bayer Medical Care, Inc. received 510(k) clearance for MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2), a DXT device. Cleared on 2026-02-13.
Details
Source
510(k) Clearance
External ID
K252891
Action Date
2026-02-13
Status
Traditional
Category
device
Product Code
DXT
Product Description
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2). Product code: DXT.
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. Bayer Medical Care, Inc. has received 3 total clearances in our database.
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 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 Bayer Medical Care, Inc. have FDA actions?
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252891" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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