# K062700: Infusomat Space Volumetric Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 26, 2006 after 45 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904518 (1990). 18 ancestors in all.
15 later devices descend from it; 5 cite it directly.
8 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023189: Vista Basic with FM System, B.Braun Medical, Inc. (2003) Summary page 1.
- K030459: Medley System with Medication Management System (MMS), Alaris Medical Systems, Inc. (2003) Summary page 1.
- K950419: The Imed Orion Infusion Pump and Administration Sets, Imed Corp. (1995) Summary page 1.
- K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets, Mcgaw, Inc. (1997) Summary page 1.

## Most influential descendants
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own
- K121613: Agilia Infusion System (2013), 2 descendants of its own
- K153731: LifeFlow Rapid Infusion Device (LifeFlow Device) (2016), 1 descendant of its own

## Recalls of this device
- Mar 23, 2012 · Class II · Z-0623-2013: Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.
- Mar 23, 2012 · Class I · Z-1992-2012: Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and 
- Jul 12, 2011 · Not classified · Z-1015-2012: If the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed, the clip catch on the inside of the pump door may break. If the clip catch is broken and the do

## Indications for use
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 crystalloids, 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/K062700
Methodology: https://510kreport.com/methodology