# K023539: Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, Transflow

- Pathway: 510(k) (Traditional)
- Applicant: Valumed
- Decided: Dec 17, 2002 after 56 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K931417 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830232: Decanter Models-Various, Steri-Sytems, Corp. (1983) Summary page 1.
- K961699: Equipment Covers, United States Surgical, A Division of Tyco Healthc (1996)

## Indications for use
The ValuMed decanting devices are devices intended for the aseptic dispensing of solutions from I.V. containers. Each device is used as follows: Bag Decanter: Used to dispense fluids from flexible bags Vial Decanter: Used to dispense fluids from glass vials Transfer Device: Used to dispense fluids from small vials, or to transfer fluid from container to container.

Source page: https://510kreport.com/device/K023539
Methodology: https://510kreport.com/methodology