# K031923: Ultrasite Valve

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 11, 2003 after 49 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). 2 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K083723: A6 Luer Access Device (2009), 31 descendants of its own
- K100434: Clave Neutron (2010), 28 descendants of its own
- K132413: MZ1000 (2013), 26 descendants of its own
- K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own

## Indications for use
The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K031923
Methodology: https://510kreport.com/methodology