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Ivex-HP96 Extended Life Filter Set

by Abbott Laboratories 510(k)

Active United States

510(k) K920736

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920736 Date23 Apr 1993ClearedStatusActive

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

9 recalls · FDA

    • Terminated Z-1389-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K920736, on the same 510(k)

    Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

  • 4 recalls, same reason

    • Terminated Z-0134-06 FDA Unclassified (pre-2012) initiated 29 Sep 2005 via K920736, on the same 510(k)
    • Terminated Z-0133-06 FDA Unclassified (pre-2012) initiated 29 Sep 2005 via K920736, on the same 510(k)
    • Terminated Z-0135-06 FDA Unclassified (pre-2012) initiated 29 Sep 2005 via K920736, on the same 510(k)
    • Terminated Z-0195-06 FDA Unclassified (pre-2012) initiated 6 May 2005 via K920736, on the same 510(k)

    Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

  • 4 recalls, same reason

    • Terminated Z-0957-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 via K920736, on the same 510(k)
    • Terminated Z-0956-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 via K920736, on the same 510(k)
    • Terminated Z-0958-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 via K920736, on the same 510(k)
    • Terminated Z-0955-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 via K920736, on the same 510(k)

    The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FPB
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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