510(k) · Cleared
Recalled · Class II · 2023Mridium 3850 Mri Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iradimed Corporation · FRN Pump, Infusion
Cleared on Mar 24, 2005 as substantially equivalent to K032771 (Medrad, Inc., 2003) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 2000. 2 of the 10 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 24, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002211 (2000). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- 1 generation backK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- This deviceK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005
- Descendant · cites it directly · 2 of its ownK090087 Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK143369 MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK242752 MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025
- Descendant · cites it directly · 0 of its ownK073051 Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc. · 2008 · Recalled
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · cites it directly2descendants
- K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016 · 2 generations on1descendant
- K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025 · 3 generations on0descendants
- K073051Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| −1 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| 0 (this device) | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | — |
| +1 | K090087 | Mridium 3860 Mri Infusion Pump/Monitoring System | Iradimed Corporation | 2009 | Class I |
| +2 | K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | 2016 | 1 |
| +3 | K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025 | — |
| +1 | K073051 | Medrad Continuum MR Infusion System with Wireless Remote Accessory | Medrad, Inc. | 2008 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032771 | Medrad Continuum MR Infusion SystemSummary page 1…725). Predicate Devices: The predicate device(s) are: the Medrad Continuum Infusion Pump System (510(k) numbers K032771 and K021988); Alaris PC-i Infusion Pump System (510(k) number K012383); and their respective infusion sets. Th… | 2003 |
| * | K021988 | Medrad Continuum MR Compatible Infusion SystemSummary page 1…Predicate Devices: The predicate device(s) are: the Medrad Continuum Infusion Pump System (510(k) numbers K032771 and K021988); Alaris PC-i Infusion Pump System (510(k) number K012383); and their respective infusion sets. These predicat… | 2002 |
| * | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…Summary page 1…re: the Medrad Continuum Infusion Pump System (510(k) numbers K032771 and K021988); Alaris PC-i Infusion Pump System (510(k) number K012383); and their respective infusion sets. These predicate devices have similar performance specifications as the M… | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2023 | Class II | Z-1310-2023 | Process control | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in… |
| Aug 24, 2012 | Class II | Z-0446-2013 | Nonconforming Material/Component | Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090087 (Iradimed Corporation, 2009) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K032771.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. The specific MRidium 3850 Series Infusion Pump System (including the MRidium 1000 Series of Infusion Sets)…
Read the full statement (254 words)
The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. The specific MRidium 3850 Series Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows:
1. Useful in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
2. Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral.
3. Useful in the following delivery modes: continuous, intermittent and bolus.
4. Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the volumetric infusion pump can be monitored or supervised by a clinician.
5. Used inside the MRI room mounted outside the 10,000 Gauss line and with shielded magnets of field strength of 3.0 Tesla or less.
The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 MRI Infusion Pump, and are used in the administration of fluids for precisely controlled infusion rates.
The infusion pump is contra-indicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHg as the high negative pressures can result in uncontrolled fluid flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050301: Mridium 3850 Mri Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050301
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026