# K191910: SpaceStation MRI

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Melsugen AG
- Decided: Mar 12, 2020 after 239 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 8 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904518 (1990). 30 ancestors in all.
No later device cites it as a predicate yet.
5 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062699: Perfusor Space Infusion Syringe Pump System, B.Braun Medical, Inc. (2006) Summary page 6.
- K062700: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2006) Summary page 6.
- K030323: Mri-Caddy, Mammendorfer Institute For Physics & Medicine GmbH (2003) Summary page 13.

## Recalls of this device
- Aug 7, 2024 · Class I · Z-2972-2024: 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 downstr
- Jun 14, 2024 · Class II · Z-2435-2024: 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 is
- Jun 14, 2024 · Class II · Z-2433-2024: 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 is
- Jun 14, 2024 · Class II · Z-2434-2024: 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 is
- Jun 14, 2024 · Class II · Z-2437-2024: 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 is
- Sep 21, 2023 · Class I · Z-0123-2024: 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 medic
- Sep 21, 2023 · Class I · Z-0124-2024: 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 medic
- Feb 7, 2022 · Class II · Z-0819-2022: 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 th

## Indications for use
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).

Source page: https://510kreport.com/device/K191910
Methodology: https://510kreport.com/methodology