MRidium 3860+ MRI infusion Pump/ Monitoring System— 510(k) K143369

Name: FDA 510(k) clearance K143369
Creator: U.S. Food and Drug Administration
Published: 2016-12-15

Substantially Equivalent

Iradimed Corporation

FDA 510(k) clearance K143369 for MRidium 3860+ MRI infusion Pump/ Monitoring System, Substantially Equivalent on 2016-12-15. Applicant: Iradimed Corporation. Device class: 2.

Clearance details

Applicant: Iradimed Corporation
Product code: Code FRN
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2014-11-25
Decision date: 2016-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Springs, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Iradimed Corporation

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K180903 — 3880 MRI Patient Monitoring System2019-03-29
K182900 — 3880 MRI Patient Monitoring System2018-12-14
K172200 — 3880 MRI Patient Monitoring System2017-10-25
K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM2009-04-07
K050301 — MRIDIUM 3850 MRI PUMP SYSTEM2005-03-24

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K143369

K-number listed on FDA's recall record

Z-1310-2023 — Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,Class II·Ongoing·Iradimed Corporation·20230224

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143369.

Data sourced from openFDA. This site is unofficial and independent of the FDA.