# K073396: Antimicrobial Ultrasite Value, Ultrasite AG

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 7, 2008 after 248 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: 3 generations back to K861563 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K053405: Bacstop, Elcam Medical Acal (2006) Summary page 1.

## Indications for use
The B. Braun Antibacterial Ultrasite Valve (Ultrasite Ag) is intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors. The Antibacterial Ultrasite Valve contains a silver based compound which may help to reduce bacterial growth on the surface and within the fluid path of the device. Testing with Ultrasite Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa,Kebsiella pneumoniae,and Enterobacteraerogenes over 96 hours. The Antibacterial Ultrasite Valve is not intended for use in the treatment of existing infections.

Source page: https://510kreport.com/device/K073396
Methodology: https://510kreport.com/methodology