Mridium 3860 MRI Infusion Pump/Monitoring System
FDA 510(k) K090087 · Iradimed Corporation
510(k) numberK090087
Submission
- Device name
- Mridium 3860 MRI Infusion Pump/Monitoring System
- Applicant
- Iradimed Corporation
Winter Park, FL, US - Received
- January 13, 2009
- Decision date
- April 7, 2009
- 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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| 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 |
| K050301 | Mridium 3850 MRI Pump SystemFRN · Traditional | 03/24/2005SE |
Questions and answers
When was Mridium 3860 MRI Infusion Pump/Monitoring System cleared by the FDA?
Mridium 3860 MRI Infusion Pump/Monitoring System (K090087) received a 510(k) decision of Substantially Equivalent on April 7, 2009, 84 days after the submission was received.
What is the product code of K090087?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.