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Lifeshield Primary Iv Set Conv. Pin. Clave; Lf Lc 5000 Plumset-Dual W/Conv Pin & Cap Port; Lifeshield Lf Macrobore Ext.

by Abbott Laboratories 510(k)

Active United States

510(k) K030002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK030002 Date27 Jan 2003ClearedStatusActive

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

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1385-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1362-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1386-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1335-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1374-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1334-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1363-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1375-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1372-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1332-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1348-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1371-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1365-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1369-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1376-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1370-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1368-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1361-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1380-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1367-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1347-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1379-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1366-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1373-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1328-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1381-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1346-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1378-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009
    • Terminated Z-1377-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009

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

Specification

510(k)

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

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