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Vial Access Cannula

by Baxter Healthcare Corp

510(k) K905664

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905664 Date15 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FMI
Device class
Class II
Regulation
21 CFR Part 880.5570
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vial Access Cannula is a blunt plastic cannula designed for needleless access to vials, classified under the product code FMI. It is intended for use with preslit injection sites and single-dose vial systems, facilitating aseptic transfer of fluids without traditional needle penetration.

This device is supplied sterile and for single-use only, ensuring patient safety and infection control. It is compatible with systems like Baxter InterLink® and is available in a 15 gauge size. Regulated under FDA 510(k) clearance (K905664), it adheres to traditional review standards for hospital use, with no MRI safety restrictions specified.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Vial Access Cannula used for?

    The Vial Access Cannula is designed for needleless access to vials, facilitating aseptic transfer of fluids without traditional needle penetration when used with preslit injection sites and single-dose vial systems.

  • Is the Vial Access Cannula reusable or single-use?

    The Vial Access Cannula is supplied sterile and for single-use only to ensure patient safety and infection control.

  • What sizes are available for the Vial Access Cannula?

    The Vial Access Cannula is available in a 15 gauge size and is compatible with systems like Baxter InterLink®.

  • How is the Vial Access Cannula regulated?

    The Vial Access Cannula is regulated under FDA 510(k) clearance (K905664) and adheres to traditional review standards for hospital use.