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Anti-I.V. Enteral Feeding System

by Viasys Medsystems

510(k) K043044

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK043044 Date6 May 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0540-2021 FDA Class II initiated 16 Oct 2020

    Detachment of the Male AIV Adaptor from the Y-Connector.

    • Terminated Z-2306-2008 FDA Unclassified (pre-2012) initiated 25 Jun 2008

    The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.

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  • Withdrawn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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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