# K974145: V3 Valve

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 6, 1998 after 64 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
Longest line of descent: 2 generations back to K942988 (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)
- K941678: Bionector, Vygon Corp. (1995). Our OCR of the scanned summary read K941679, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bionector”.
- K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1.

## Indications for use
The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting.

Source page: https://510kreport.com/device/K974145
Methodology: https://510kreport.com/methodology