# K050207: BD Posiflow Positive Displacement Valve

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Apr 7, 2005 after 69 days
- Product code: FPA (Set, Administration, Intravascular)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Posiflow Positive Displacement Valve: named in the summary without a submission number

## Indications for use
The BD Posiflow Positive Displacement Valve is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. The BD Positive Displacement Valve can be used by itself or as a component on an extension/infusion set, a vial adapter, or as a connector to convert a standard access site to a needleless access site.

Source page: https://510kreport.com/device/K050207
Methodology: https://510kreport.com/methodology
