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Vacuette 450083

by Greiner Bio - One GmbH

Vacuette 450083 is a Class II device made by Greiner Bio - One GmbH, cleared under FDA 510(k) K121908 on 25 Jul 2012 (2 earlier submissions) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 19120017570254), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number19120017570254 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121908 Date25 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121908 decided 25 Jul 2012 Active· +2 more in the status table
  • FDA GUDID UDI-DI 19120017570254 listed 23 Sep 2016 Listed

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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K011786
  2. Recall initiated FDA recalls Z-0797-03
  3. Cleared FDA 510(k) K080235
  4. Cleared FDA 510(k) K121908
  5. Recall initiated FDA recalls Z-0835-2013
  6. Listed FDA GUDID 19120017570254

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vacuette
Generic name
Basic intravenous administration set, invasive
Model / Ref / Catalog
450083
Primary DI / UDI-DI
19120017570254
510(k) Number
FDA product code
FMI
GMDN term
Basic intravenous administration set, invasive
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic intravenous administration set, invasive

Cleared under the same submission (K011786)

and 8 more cleared under K011786

Cleared under the same submission (K080235)

and 8 more cleared under K080235

Similar devices

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)