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Vacuette Safety Blood Collection Set

by Greiner Vacuette North America, Inc.

510(k) K011786

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 NumberK011786 Date12 Jul 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0835-2013 FDA Class II initiated 1 Feb 2013

    The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.

    • Terminated Z-0797-03 FDA Unclassified (pre-2012) initiated 10 Mar 2003 on shared 510(k) K011786

    The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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