Class Class II
MRidium 3870 MRI Infusion Pump System (3870) (K242752)
Description
MRidium 3870 MRI Infusion Pump System (3870) by Iradimed Corporation, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242752
Clearance Date2025-05-28
Clearance TypeTraditional
Product CodeFRN
Regulation Number880.5725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242752
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MRidium 3870 MRI Infusion Pump System (3870) (K242752) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | 2016 |
Trace the full predicate network for K242752
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.