Mridium 3850 MRI Pump System
FDA 510(k) K050301 · Iradimed Corporation
510(k) numberK050301
Submission
- Device name
- Mridium 3850 MRI Pump System
- Applicant
- Iradimed Corporation
Winter Park, FL, US - Received
- February 8, 2005
- Decision date
- March 24, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | 05/28/2025SE |
| K180903 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 03/29/2019SE |
| K182900 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 12/14/2018SE |
| K172200 | 3880 MRI Patient Monitoring SystemMWI · Traditional | 10/25/2017SE |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring SystemFRN · Traditional | 12/15/2016SE |
| K090087 | Mridium 3860 MRI Infusion Pump/Monitoring SystemFRN · Traditional | 04/07/2009SE |
Questions and answers
When was Mridium 3850 MRI Pump System cleared by the FDA?
Mridium 3850 MRI Pump System (K050301) received a 510(k) decision of Substantially Equivalent on March 24, 2005, 44 days after the submission was received.
What is the product code of K050301?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.