510(k) · Cleared
Recalled · Class II · 2014Medrad Continuum MR Infusion System with Wireless Remote Accessory
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 30, 2008 as substantially equivalent to K061128 (Medrad, Inc., 2006) and 1 other predicate after a 214-day review. Its family tree reaches back 3 generations to 2000. 1 of the 8 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- May 30, 2008
- Review
- 214 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002211 (2000). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- 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)
- 1 generation backK050301 Mridium 3850 Mri Pump SystemIradimed Corporation · 2005 · Recalled
- This deviceK073051 Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc. · 2008
Class I recalls in this family
- K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| −2 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| −1 | K050301 | Mridium 3850 Mri Pump System | Iradimed Corporation | 2005 | 2 |
| 0 (this device) | K073051 | Medrad Continuum MR Infusion System with Wireless Remote Accessory | Medrad, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K061128 | Modification to Medrad Continuum MR Infusion SystemSummary page 1…sion Pump - Class 11(see 21 CFR 880.5725) COMMON NAME: Peristaltic Pump PRODUCT CODE: FRN PREDICATE DEVICES: K061128, MEDRAD Continuum MR Compatible Infusion System (3T Proximity)… | 2006 |
| * | K050301 | Mridium 3850 Mri Pump SystemSummary page 1…ATE DEVICES: K061128, MEDRAD Continuum MR Compatible Infusion System (3T Proximity) K050301, Iradimed MRidium 3850 MRI Infusion Pump System INDICATIONS FOR USE: The MEDRAD Continuum MR Infusion System with… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2014 | Class II | Z-1673-2014 | Component design/selection | There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. |
| Apr 18, 2012 | Class II | Z-0595-2013 | Nonconforming Material/Component | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating… |
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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K061128.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other 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/K073051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073051: Medrad Continuum MR Infusion System with Wireless Remote Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073051
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