510(k) Report

FDA applicant

Iradimed Corporation

Winter Springs, FL7 decisions2005–20253 recalls

FDA records 7 decisions for Iradimed Corporation (Winter Springs, FL) from 2005 to 2025: 7 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. 3 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Iradimed Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12016: 12017: 12018: 12019: 12025: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2012: 12013: 1, 1 Class I2023: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Iradimed Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRNPump, Infusion4decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)3decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 258 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 217 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050301Mridium 3850 Mri Pump SystemIradimed Corporation · 20052cite it
  • K1722003880 MRI Patient Monitoring SystemIradimed Corporation · 20172cite it
  • K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 20091cites it
  • K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 20161cites it

What has FDA decided for it lately?

  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025
  • K1809033880 MRI Patient Monitoring SystemIradimed Corporation · 2019
  • K1829003880 MRI Patient Monitoring SystemIradimed Corporation · 2018
  • K1722003880 MRI Patient Monitoring SystemIradimed Corporation · 2017
  • K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 20161 recall
  • K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 20091 Class I recall
  • K050301Mridium 3850 Mri Pump SystemIradimed Corporation · 20052 recalls

All 7 as Iradimed Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K050301Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe…Feb 24, 2023Class II
  • K090087MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the…Jul 1, 2013Class I
  • K050301The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set…Aug 24, 2012Class II