# K983005: Perfusor Compact

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Feb 4, 1999 after 160 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: 1 generation back to K844719 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844719: 360 Infuser, Bd Becton Dickinson Vacutainer Systems Preanalytic (1985) Summary page 2.
- K902409: Becton Dickinson 360 Infuser (TM) System, Bd Becton Dickinson Vacutainer Systems Preanalytic (1990) Summary page 2.

## Indications for use
The Perfusor® compact is a transportable syringe infusion pump that provides infusions of parenteral and enteral fluids. The system created by using syringes validated for use with the Perfusor® compact is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a drive mechanism. The Perfusor® compact is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Perfusor® compact is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Perfusor® compact is performed by the trained healthcare provider per a physician’s order.

Source page: https://510kreport.com/device/K983005
Methodology: https://510kreport.com/methodology