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I.V. Sets Walrus Brand Various Configur-

by Medical Parameters, Inc.

510(k) K830755

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

22 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 NumberK830755 Date28 Apr 1983ClearedStatusActive

Recalls

22 recalls · FDA

    • Terminated Z-0097-2019 FDA Class II initiated 7 Sep 2018

    Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.

  • 19 recalls, same reason

    • Terminated Z-1121-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1128-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1129-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1118-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1120-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1119-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1116-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1123-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1112-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1114-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1130-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1126-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1125-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1127-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1115-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1124-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1122-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1113-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-1117-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010

    Sterility may be compromised.

  • 2 recalls, same reason

    • Terminated Z-1490-2009 FDA Unclassified (pre-2012) initiated 11 Feb 2009
    • Terminated Z-1489-2009 FDA Unclassified (pre-2012) initiated 11 Feb 2009

    Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

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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