# K142596: Infusomat Space Volumetric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 18, 2015 after 276 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
6 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083689: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2009) Summary page 4.

## Recalls of this device
- 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

## Indications for use
The Infusomat® Space Volumetric Infusion Pump System is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes include intravenous, intra-arterial, subcutaneous, and epidural. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities.

Source page: https://510kreport.com/device/K142596
Methodology: https://510kreport.com/methodology