510(k) · Cleared
Recalled · Class I · 2024SpaceStation MRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun Melsugen AG · MRZ Accessories, Pump, Infusion
Cleared on Mar 12, 2020 as substantially equivalent to K062699 (B.Braun Medical, Inc., 2006) and 2 other predicates after a 239-day review. Its family tree reaches back 4 generations to 1990. 5 of the 31 devices in its family, counting itself, have a Class I recall. It has been recalled 8 times, including 3 Class I recalls.
- Decided
- Mar 12, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- 8 (3 Class I)
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904518 (1990). 30 ancestors in all, the oldest K820133 (1982). No later device cites it as a predicate yet. 5 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- 1 generation backK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- This deviceK191910 SpaceStation MRIB. Braun Melsugen AG · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| −1 | K062699 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2006 | — |
| 0 (this device) | K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 3 | 0 |
| 2006 | 1 | 1 |
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.
5 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K062699 | Perfusor Space Infusion Syringe Pump SystemSummary page 6…where the summary is organized in 3 sub-sections which correspond to each device bundled within the subject 510(k): • Section A) MRI conditional labeling changes to K062699 Perfusor Space Infusion Syringe Pump (See pages 2 - 4) • Section B) MRI conditional labeling changes to K062700 Infus… | 2006 |
| * | K062700 | Infusomat Space Volumetric Infusion Pump SystemSummary page 6…ection A) MRI conditional labeling changes to K062699 Perfusor Space Infusion Syringe Pump (See pages 2 - 4) • Section B) MRI conditional labeling changes to K062700 Infusomat Space Volumetric Infusion Pump (See pages 5 - 7) • Section C) Traditional 510(k) SpaceStation MRI (See page… | 2006 |
| * | K030323 | Mri-CaddySummary page 13…Classification Panel: General Hospital C02) Legally Marketed Predicate Device(s) MRI-Caddy (MIPM Mammendorfer Institut für Physik und Medizin GmbH) - K030323 C03) Device Description The SpaceStation MRI is a movable MRI Rack System for the operation of up to four B.Braun Sp… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2024 | Class I | Z-2972-2024 | Component design/selection | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms.… |
| Jun 14, 2024 | Class II | Z-2435-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Jun 14, 2024 | Class II | Z-2433-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Jun 14, 2024 | Class II | Z-2434-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Jun 14, 2024 | Class II | Z-2437-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Sep 21, 2023 | Class I | Z-0123-2024 | Component design/selection | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent… |
| Sep 21, 2023 | Class I | Z-0124-2024 | Component design/selection | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent… |
| Feb 7, 2022 | Class II | Z-0819-2022 | Under Investigation by firm | Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion. |
The 5 latest of 8 recalls; the web page lists all.
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.
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 14 of the 30 ancestors have a recall of any class; 4 have a Class I recall.
- 3 other devices also cite its predicate K062699.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients. The product is intended to be used by qualified healthcare professionals. The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults…
Read the full statement (291 words)
The SpaceStation MRI is a MRI (Magnetic Resonance Imaging) System Rack for the operation of Space Infusion Pumps during MRI examinations (MRI procedures) of adult, pediatric or neonatal patients.
The product is intended to be used by qualified healthcare professionals.
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).
The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. (only road ambulances).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191910: SpaceStation MRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191910
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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