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Sureone Insulin Syringe, 31 Gauge X 5/16

by Hosuk Co., Ltd.

510(k) K021197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 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 · Special NumberK021197 Date26 Apr 2002ClearedStatusActive

Recalls

10 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0575-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0576-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0571-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0573-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0570-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0569-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009
    • Terminated Z-0574-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009

    Needles are becoming dislodged from the barrels.

    • Terminated Z-0572-2010 FDA Unclassified (pre-2012) initiated 27 Oct 2009

    Needles are becoming dislodged from the barrels

  • 2 recalls, same reason

    • Terminated Z-2248-2009 FDA Unclassified (pre-2012) initiated 21 Aug 2009
    • Terminated Z-2247-2009 FDA Unclassified (pre-2012) initiated 21 Aug 2009

    Needles separate from the barrels of the syringes

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  • Withdrawn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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