510(k) · Cleared
ClearedModification to Medrad Continuum MR 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 May 22, 2006 as substantially equivalent to K032771 (Medrad, Inc., 2003) after a 28-day review. Its family tree reaches back 2 generations to 2002. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 22, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021988 (2002). 4 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK021988 Medrad Continuum MR Compatible Infusion SystemMedrad, Inc. · 2002 · Recalled
- 1 generation backK032771 Medrad Continuum MR Infusion SystemMedrad, Inc. · 2003 · Recalled
- This deviceK061128 Modification to Medrad Continuum MR Infusion SystemMedrad, Inc. · 2006
- 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
- K090087 Mridium 3860 Mri Infusion Pump/Monitoring Systemcites it directly · 2009
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 | K021988 | Medrad Continuum MR Compatible Infusion System | Medrad, Inc. | 2002 | 1 |
| −1 | K032771 | Medrad Continuum MR Infusion System | Medrad, Inc. | 2003 | 1 |
| 0 (this device) | K061128 | Modification to Medrad Continuum MR Infusion System | Medrad, Inc. | 2006 | — |
| +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 |
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.
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? (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 |
|---|---|---|---|
| * | K032771 | Medrad Continuum MR Infusion SystemSummary page 1…MEDRAD Continuum MR Infusion System PREDICATE DEVICE: MEDRAD MR Continuum Infusion System (K032771) INTENDED USE: The MEDRAD Continuum MR Compatible Infusion System is… | 2003 |
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? (1 Class I)
No FDA recall names this device.
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 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 MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside 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 summary.
https://510kreport.com/device/K061128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061128: Modification to Medrad Continuum MR 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/K061128
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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