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Twin-Fusor/Uni-Fusor Blood & Fluid Infusion Cuff

by Statlabs, Inc.

510(k) K893519

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK893519 Date15 Aug 1989ClearedStatusActive

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-0464-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0470-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0469-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0461-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0468-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0471-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0466-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0463-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0462-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0465-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519
    • Terminated Z-0467-2009 FDA Unclassified (pre-2012) initiated 20 Sep 2008 on shared 510(k) K893519

    Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.

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  • Withdrawn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
KZB
Device Class
Class I
Regulation
21 CFR Part 866.2170
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent