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Millennium Huber Plus Safety Infusion Set

by Millennium Medical Distribution, Inc.

510(k) K993848

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK993848 Date27 Jan 2000ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0862-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2010
    • Terminated Z-0861-2010 FDA Unclassified (pre-2012) initiated 14 Jan 2010

    After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.

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  • Withdrawn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