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Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter

by Baxter Healthcare Corp

510(k) K964850

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK964850 Date25 Feb 1997ClearedStatusActive

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0641-06 FDA Unclassified (pre-2012) initiated 15 Dec 2005
    • Terminated Z-0642-06 FDA Unclassified (pre-2012) initiated 15 Dec 2005
    • Terminated Z-0652-06 FDA Unclassified (pre-2012) initiated 15 Dec 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-1100-05 FDA Unclassified (pre-2012) initiated 6 Jul 2005

    Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.

    • Terminated Z-1153-03 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.

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  • Withdrawn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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