# K083689: Infusomat Space Volumetric Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 1, 2009 after 201 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: 4 generations back to K904518 (1990). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
7 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062700: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2006) Summary page 1.
- K011975: Horizon Outlook with Dosecom, B.Braun Medical, Inc. (2001) Summary page 1.
- K032233: Medley Pca Module, Model 8120, Alaris Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K121613: Agilia Infusion System (2013), 2 descendants of its own
- K210075: Vigilant Software Suite – Vigilant Master Med (2022), 0 descendants of its own
- K210073: Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo (2022), 0 descendants of its own
- K142596: Infusomat Space Volumetric Infusion Pump (2015), 0 descendants 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 is an electrical, external, volumetric infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

Source page: https://510kreport.com/device/K083689
Methodology: https://510kreport.com/methodology