Skip to content

Solution Administration Sets

by Travenol Laboratories, S.A. 510(k)

Active United States

510(k) K860272

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860272 Date18 Mar 1986ClearedStatusActive

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

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0605-2016 FDA Class II initiated 30 Nov 2015
    • Terminated Z-0606-2016 FDA Class II initiated 30 Nov 2015

    Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

  • 2 recalls, same reason

    • Terminated Z-0473-2012 FDA Unclassified (pre-2012) initiated 6 Dec 2011
    • Terminated Z-0472-2012 FDA Unclassified (pre-2012) initiated 6 Dec 2011

    During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.

  • 3 recalls, same reason

    • Terminated Z-1426-05 FDA Unclassified (pre-2012) initiated 3 Aug 2005
    • Terminated Z-1425-05 FDA Unclassified (pre-2012) initiated 3 Aug 2005
    • Terminated Z-1427-05 FDA Unclassified (pre-2012) initiated 3 Aug 2005

    The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

    • Terminated Z-1150-03 FDA Unclassified (pre-2012) initiated 16 Jul 2003

    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

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

Other devices from Travenol Laboratories, S.A.

See all devices from Travenol Laboratories, S.A. →