# K022575: Perfusor Compact with FM System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 21, 2002 after 19 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904518 (1990). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994375: Horizon Light, B.Braun Medical, Inc. (2000) Summary page 1.
- K950419: The Imed Orion Infusion Pump and Administration Sets, Imed Corp. (1995) Summary page 1.

## Most influential descendants
- K062699: Perfusor Space Infusion Syringe Pump System (2006), 4 descendants of its own
- K092313: Perfusor Space Infusion Syringe Pump System (2009), 1 descendant of its own
- K191910: SpaceStation MRI (2020), 0 descendants of its own
- K172831: Perfusor® Space Syringe Infusion Pump System (2018), 0 descendants of its own
- K111381: Medi-Sis Syringe Infusion System (2012), 0 descendants of its own

## Indications for use
The intended use of the Perfusor@compact withfnz system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of thefnz system extends the abilities of the Perfusor@compact and creates a versatile system that will enhance the administration and management of infusion therapy. Thefnz systenz may be used in a variety of configurations depending on the level of needs of the healthcare facility. The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters. The Perfusormompact withfin syste~izis intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting

Source page: https://510kreport.com/device/K022575
Methodology: https://510kreport.com/methodology