Iradimed Corporation
Orlando, FL, US
IRADIMED CORPORATION appears in FDA device records in Orlando, FL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Iradimed Corporation between 2005 and 2025. The busiest year on record is 2005, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | FRN | Substantially Equivalent | |
| K180903 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | |
| K182900 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | |
| K172200 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | FRN | Substantially Equivalent | |
| K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM | FRN | Substantially Equivalent | |
| K050301 | MRIDIUM 3850 MRI PUMP SYSTEM | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005053560 | 3005053560 | IRADIMED CORPORATION | 12705 Ingenuity Dr, Orlando, FL 32826 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1310-2023 | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion. | Class II | Open, Classified | |
| Z-1874-2013 | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans. | The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value. | Class I | Terminated | |
| Z-0446-2013 | The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications. | Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain