K252891 is an FDA 510(k) clearance for the MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on February 13, 2026, 155 days after receiving the submission on September 11, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K252891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2025 |
| Decision Date | February 13, 2026 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |