510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

Mridium 3860 Mri Infusion Pump/Monitoring System

K090087510(k) TraditionalCleared Apr 7, 200984-day reviewClass II21 CFR 880.5725Recalls 2 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Iradimed Corporation · FRN Pump, Infusion

Cleared on Apr 7, 2009 as substantially equivalent to K050301 (Iradimed Corporation, 2005) and 5 other predicates after an 84-day review. Its family tree reaches back 3 generations to 2000. 2 of the 11 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided
Apr 7, 2009
Review
84 days
Class
Class II
Product code
FRN
Recalls
2 (1 Class I)
Predicates
6

Its longest line of descent runs back 3 generations to K002211 (2000). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2016: 1 descendant cleared2025: 1 descendant clearedK002211 · Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151 · Baxter Healthcare Corp · 2000 · recalledK012383 · Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C · Alaris Medical Systems, Inc. · 2001 · Class I recallK050301 · Mridium 3850 Mri Pump System · Iradimed Corporation · 2005 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K050301 · Mridium 3850 Mri Pump System · Iradimed Corporation · 2005 · recalledK012383 · Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C · Alaris Medical Systems, Inc. · 2001 · Class I recallK002211 · Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump 2M8151 · Baxter Healthcare Corp · 2000 · recalled0
  1. Root · 3 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
  2. 2 generations backK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
  3. 1 generation backK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
  4. This deviceK090087 Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009
  5. Descendant · cites it directly · 1 of its ownK143369 MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK242752 MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

Class I recalls in this family

  • K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…direct predicate · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016 · cites it directly1descendant
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002211Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump…Baxter Healthcare Corp20004
−2K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem…Alaris Medical Systems, Inc.2001Class I
−1K050301Mridium 3850 Mri Pump SystemIradimed Corporation20052
0 (this device)K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation2009—
+1K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation20161
+2K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202510
FIG. 1 — Lineage of K090087, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K050301Mridium 3850 Mri Pump System
Summary page 1
…and Pulse Oximeter. Classification: Class lI (see 21 CFR - 870.5725 and 870.2700). Predicate Devices: The predicate device(s) are: MRidium 3850 Infusion Pump System (K050301); Nonin 7500FO Pulse Oximeter; the Medrad Continuum Infusion Pump System (510(k) numbers K032771, K021988, and K061128); Alaris P…
Iradimed Corporation20052
*K032771Medrad Continuum MR Infusion System
Summary page 1
…evices: The predicate device(s) are: MRidium 3850 Infusion Pump System (K050301); Nonin 7500FO Pulse Oximeter; the Medrad Continuum Infusion Pump System (510(k) numbers K032771, K021988, and K061128); Alaris PC-I Infusion Pump System (510(k) number K012383); the CME Bodyguard 323 Infusion Pump with Pulse…
Medrad, Inc.20031
*K021988Medrad Continuum MR Compatible Infusion System
Summary page 1
…The predicate device(s) are: MRidium 3850 Infusion Pump System (K050301); Nonin 7500FO Pulse Oximeter; the Medrad Continuum Infusion Pump System (510(k) numbers K032771, K021988, and K061128); Alaris PC-I Infusion Pump System (510(k) number K012383); the CME Bodyguard 323 Infusion Pump with Pulse Oximeter…
Medrad, Inc.20021
*K061128Modification to Medrad Continuum MR Infusion System
Summary page 1
…device(s) are: MRidium 3850 Infusion Pump System (K050301); Nonin 7500FO Pulse Oximeter; the Medrad Continuum Infusion Pump System (510(k) numbers K032771, K021988, and K061128); Alaris PC-I Infusion Pump System (510(k) number K012383); the CME Bodyguard 323 Infusion Pump with Pulse Oximeter (K060479); Th…
Medrad, Inc.2006—
*K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…
Summary page 1
…); Nonin 7500FO Pulse Oximeter; the Medrad Continuum Infusion Pump System (510(k) numbers K032771, K021988, and K061128); Alaris PC-I Infusion Pump System (510(k) number K012383); the CME Bodyguard 323 Infusion Pump with Pulse Oximeter (K060479); The MRidium 3860 Infusion Pump System is substantially equiv…
Alaris Medical Systems, Inc.2001Class I
*K060479Modification to Bodyguard Infusion Pump System
Summary page 1
…System (510(k) numbers K032771, K021988, and K061128); Alaris PC-I Infusion Pump System (510(k) number K012383); the CME Bodyguard 323 Infusion Pump with Pulse Oximeter (K060479); The MRidium 3860 Infusion Pump System is substantially equivalent to these predicate devices. Device Description: The MRidiu…
Caesarea Medical Electronics, Ltd.2006—
*—Nonin 7500FO Pulse Oximeter
Named without a submission number
—

Also cleared against K050301: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation20161

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 24, 2023Class IIZ-1310-2023Process controlCertain 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…
Jul 1, 2013Class IZ-1874-2013Software Manufacturing/Software DeploymentThe Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is…

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

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 6 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K143369 (Iradimed Corporation, 2016) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K050301.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The MRidium 3860 Series MRI Infusion Pump/Monitoring System indications for use are as follows: 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…

Read the full statement (252 words)

The MRidium 3860 Series MRI Infusion Pump/Monitoring System indications for use are as follows:

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. 4.

This device is available for sale only upon the order of a physician or other related licensed medical professional, and is 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 as stated in the FDA summary.

Also cleared against K050301

1 other device cites the same predicate.

  • K073051Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc. · 20082 recalls

More from Iradimed Corporation

7 FDA decisions under this applicant name. See the company

  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025
  • K1809033880 MRI Patient Monitoring SystemIradimed Corporation · 2019
  • K1829003880 MRI Patient Monitoring SystemIradimed Corporation · 2018
  • K1722003880 MRI Patient Monitoring SystemIradimed Corporation · 2017
  • K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 20161 recall

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K090087 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090087: Mridium 3860 Mri Infusion Pump/Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090087

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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