# K243392: Infusomat® Space Volumetric Infusion Pump Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 24, 2025 after 266 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142036: Infusomat Space Volumetric Infusion Pump Administration Sets, B.Braun Medical, Inc. (2014) Summary page 5.

## Indications for use
The Infusomat® Space Volumetric Pump Administration Sets are 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 sets are 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 Infusomat Space Volumetric Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

Source page: https://510kreport.com/device/K243392
Methodology: https://510kreport.com/methodology