# K092313: Perfusor Space Infusion Syringe Pump System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 4, 2009 after 97 days
- Product code: MEA (Pump, Infusion, Pca)
- 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: 4 generations back to K904518 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062699: Perfusor Space Infusion Syringe 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
- K172831: Perfusor® Space Syringe Infusion Pump System (2018), 0 descendants of its own

## Recalls of this device
- Jun 14, 2024 · Class II · Z-2436-2024: 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-2435-2024: 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-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
- 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 Infusion Syringe Pump System is an electrical, external, syringe 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/K092313
Methodology: https://510kreport.com/methodology