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IV Administration Sets with Needleless Access Devices

by Venetec Intl., Inc.

510(k) K980992

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 NumberK980992 Date28 May 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1539-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009

    The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.

    • Terminated Z-0925-03 FDA Unclassified (pre-2012) initiated 12 May 2003

    Set tubing disconnected from the male luer lock during use on patients. Misassembled.

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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