K242752 is an FDA 510(k) clearance for the MRidium 3870 MRI Infusion Pump System (3870). This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Iradimed Corporation (Winter Springs, US). The FDA issued a Cleared decision on May 28, 2025, 258 days after receiving the submission on September 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2024 |
| Decision Date | May 28, 2025 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |