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Sureone Insulin Syringe

by Hosuk Co., Ltd.

510(k) K002921

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK002921 Date18 Oct 2000ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0005-04 FDA Unclassified (pre-2012) initiated 24 Feb 2003
    • Terminated Z-0003-04 FDA Unclassified (pre-2012) initiated 24 Feb 2003
    • Terminated Z-0004-04 FDA Unclassified (pre-2012) initiated 24 Feb 2003

    The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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