510(k) · Cleared
Recalled · Class II · 2023MRidium 3860+ MRI infusion Pump/ Monitoring 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 Dec 15, 2016 as substantially equivalent to K090087 (Iradimed Corporation, 2009) after a 751-day review. Its family tree reaches back 4 generations to 2000. 2 of the 11 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 15, 2016
- Review
- 751 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002211 (2000). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- 3 generations backK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- 2 generations backK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
- 1 generation backK090087 Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Recalled (Class I)
- This deviceK143369 MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016
- Descendant · cites it directly · 0 of its ownK242752 MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| −3 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| −2 | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | 2 |
| −1 | K090087 | Mridium 3860 Mri Infusion Pump/Monitoring System | Iradimed Corporation | 2009 | Class I |
| 0 (this device) | K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | Iradimed Corporation | 2016 | — |
| +1 | K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K090087 | Mridium 3860 Mri Infusion Pump/Monitoring SystemSummary page 4…(see 21 CFR 880.5725) Product Code: FRN Primary Predicate/Legally Marketed Device to Which Equivalence is Claimed: MRidium 3860 MRI Infusion Pump/Monitoring System: K090087 (Marketed as MRidium 3860+ MRI Infusion Pump/Monitoring System) Device Description: The MRidium 3860+ MRI Infusion Pump/Monitor… | 2009 |
| † | K053269 | Masimo Set Rad-8 Pulse Oximeter | 2005 |
| † | K071415 | Digital Pulse Oximeter, Model 7500FO | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | 2025 | 0 |
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… |
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.
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 7 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K242752 (Iradimed Corporation, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 3860+ MRI Infusion Pump/Monitoring System is intended for: - General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, 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 system is useful in the administration of fluids requiring precisely…
Read the full statement (241 words)
The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for:
- General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, 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 system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.
- The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less.
- This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
- The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI.
The infusion pump is contraindicated 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143369 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143369: MRidium 3860+ MRI infusion Pump/ Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143369
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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