510(k) · Cleared
Recalled · 2005Medrad Continuum MR Compatible Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · FRN Pump, Infusion
Cleared on Aug 29, 2002 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK021988 Medrad Continuum MR Compatible Infusion SystemMedrad, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK032771 Medrad Continuum MR Infusion SystemMedrad, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK061128 Modification to Medrad Continuum MR Infusion SystemMedrad, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
- 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K090087 Mridium 3860 Mri Infusion Pump/Monitoring Systemcites it directly · 2009
Most influential descendants
Showing 5 of 8 · See all- K032771Medrad Continuum MR Infusion SystemMedrad, Inc. · 2003 · cites it directly7descendants
- K061128Modification to Medrad Continuum MR Infusion SystemMedrad, Inc. · 2006 · 2 generations on4descendants
- K050301Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · cites it directly4descendants
- K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation · 2009 · cites it directly2descendants
- K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021988 | Medrad Continuum MR Compatible Infusion System | Medrad, Inc. | 2002 | — |
| +1 | K032771 | Medrad Continuum MR Infusion System | Medrad, Inc. | 2003 | 1 |
| +2 | K061128 | Modification to Medrad Continuum MR Infusion System | Medrad, Inc. | 2006 | — |
| +1 | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | 2 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 1 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2005 | Not classified | Z-0841-05 | Other | Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket. |
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 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032771 (Medrad, Inc., 2003) has gone furthest, with 7 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.
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 Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021988: Medrad Continuum MR Compatible Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021988
Report an extraction error
Are you the manufacturer?
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