# Iradimed Corporation

- Location (FDA's records): Winter Springs, FL
- FDA decisions: 7 (2005–2025): 7 510(k) clearances
- Product codes: FRN (4), MWI (3)
- 510(k) review time since 2016: median 258 days, against 217 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 18 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medrad, Inc.: 5 (https://510kreport.com/company/medrad)
- Alaris Medical Systems, Inc.: 2 (https://510kreport.com/company/alaris-medical-systems)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Caesarea Medical Electronics, Ltd.: 1 (https://510kreport.com/company/caesarea-medical-electronics)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- MIPM Mammendorfer Institut für Physik und Medizin GmbH: 1 (https://510kreport.com/company/mipm-mammendorfer-institut-fur-physik-und-medizin)
- Invivo Research, Inc.: 1 (https://510kreport.com/company/invivo-research)

## Firms that cite its devices most
- Medrad, Inc.: 1 (https://510kreport.com/company/medrad)

## Its most-cited devices
- K050301: Mridium 3850 Mri Pump System (2005), cited by 2
- K172200: 3880 MRI Patient Monitoring System (2017), cited by 2
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (2009), cited by 1
- K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System (2016), cited by 1

## Recent decisions
- K242752: MRidium 3870 MRI Infusion Pump System (3870) (May 28, 2025)
- K180903: 3880 MRI Patient Monitoring System (Mar 29, 2019)
- K182900: 3880 MRI Patient Monitoring System (Dec 14, 2018)
- K172200: 3880 MRI Patient Monitoring System (Oct 25, 2017)
- K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System (Dec 15, 2016)
- K090087: Mridium 3860 Mri Infusion Pump/Monitoring System (Apr 7, 2009)
- K050301: Mridium 3850 Mri Pump System (Mar 24, 2005)

Source page: https://510kreport.com/company/iradimed