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Infusion Pump & IV Sets #4000

by Omni-Glow, Inc.

510(k) K832755

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 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 NumberK832755 Date3 Nov 1983ClearedStatusActive

Recalls

16 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-1357-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1341-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1351-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1352-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1355-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1358-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1356-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1353-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755
    • Terminated Z-1354-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 on shared 510(k) K832755

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

    • Terminated Z-0505-06 FDA Unclassified (pre-2012) initiated 9 Jan 2006 on shared 510(k) K832755

    The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

  • 4 recalls, same reason

    • Terminated Z-0955-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 on shared 510(k) K832755
    • Terminated Z-0958-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003
    • Terminated Z-0959-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 on shared 510(k) K832755
    • Terminated Z-0957-03 FDA Unclassified (pre-2012) initiated 9 Jun 2003 on shared 510(k) K832755

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

    • Terminated Z-0915-03 FDA Unclassified (pre-2012) initiated 13 May 2003

    IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

    • Terminated Z-0936-03 FDA Unclassified (pre-2012) initiated 13 May 2003 on shared 510(k) K832755

    The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent