Skip to content

Ultrasite Valve

by B. Braun Medical Inc. 510(k)

Active United States

510(k) K031923

Overview

The Ultrasite Valve is a needle-free injection port and Luer-activated valve designed for use in intravenous applications. It facilitates the aspiration, injection, or gravity flow of fluids upon the insertion of a male Luer fitting.

This device is a positive displacement, capless needleless connector that is DEHP-free and latex-free. It is compatible with Luer Lock and Luer Slip fittings, features a microbial barrier design, and is pressure rated to 300 psi. The valve is supplied in boxes of 100 units and has received FDA 510k clearance.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031923 Date11 Aug 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FPA
FDA applicant
B.Braun Medical, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from B. Braun Medical Inc.

See all devices from B. Braun Medical Inc. →

Questions

  • What is the primary function of the Ultrasite Valve?

    The Ultrasite Valve is a needle-free, Luer-activated injection port used for intravenous applications. It allows for the safe aspiration, injection, or gravity flow of fluids when a male Luer fitting is inserted into the device.

  • Is the Ultrasite Valve compatible with standard Luer fittings?

    Yes, the valve is designed for versatility and is compatible with both Luer Lock and Luer Slip fittings, ensuring it can be integrated into various intravenous setups.

  • How is the Ultrasite Valve supplied and what are its material properties?

    The device is supplied in boxes of 100 units. It is manufactured to be both DEHP-free and latex-free, and it features a microbial barrier design to support clinical safety standards.

  • What is the pressure rating for this needleless connector?

    The Ultrasite Valve is pressure rated to 300 psi, which allows it to maintain integrity during standard clinical procedures requiring fluid administration or aspiration.