Data / Medical devices / United States / Iradimed Corporation
Iradimed Corporation: FDA-registered device maker in Orlando, FL, United States, 7 510(k) clearances
Iradimed Corporation is registered with the FDA (registration 3005053560) in Orlando, FL, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 28, 2025. 3 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005053560
- Address
- 12705 Ingenuity Dr, Orlando, FL, United States, 32826
- Owner or operator
- IRADIMED CORPORATION (9070201)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 11, 2005
- Registered through
- 2026
- Brand names listed
- 1000 Series IV Sets, 1119 MRI IV Pole, 3880 MRI Patient Monitoring System, Hextrode MRI ECG Electrode, MRidium 3850 MRI Infusion Pump System, MRidium 3860 MRI Infusion Pump System, MRidium 3870 MRI Infusion Pump System, MRidium IV Pole and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2025 | K242752 | MRidium 3870 MRI Infusion Pump System (3870) | FRN | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| March 29, 2019 | K180903 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| December 14, 2018 | K182900 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| October 25, 2017 | K172200 | 3880 MRI Patient Monitoring System | MWI | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| December 15, 2016 | K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | FRN | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| April 7, 2009 | K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM | FRN | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
| March 24, 2005 | K050301 | MRIDIUM 3850 MRI PUMP SYSTEM | FRN | Substantially Equivalent | Iradimed Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 24, 2023 | 91846 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 1, 2013 | 65778 | Class I | Terminated | 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 medica | 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. | accessdata.fda.gov |
| August 24, 2012 | 63675 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Stand, Infusion
- All makers of Electrode, Electrocardiograph
- All makers of Set, I.V. Fluid Transfer
Updated May 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.