# K172831: Perfusor® Space Syringe Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 12, 2018 after 267 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 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). 18 ancestors in all.
No later device cites it as a predicate yet.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092313: Perfusor Space Infusion Syringe Pump System, B.Braun Medical, Inc. (2009) Summary page 4.
- K062699: Perfusor Space Infusion Syringe Pump System, B.Braun Medical, Inc. (2006) Summary page 4.

## Recalls of this device
- 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
- 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 Perfusor® Space Syringe Infusion Pump System is intended for use on adults, pediatrics and neonates for the intermittent or continuous delivery of parenteral fluids, enteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes include intravenous, intra-arterial, subcutaneous, epidural and enteral. The Perfusor® Space Syringe Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities and for medical ground and/or air transport situations.

Source page: https://510kreport.com/device/K172831
Methodology: https://510kreport.com/methodology