510(k) Report

FDA applicant

Greiner Bio-One North America, Inc.

Baldwin, MD10 decisions2006–20245 recalls

FDA records 10 decisions for Greiner Bio-One North America, Inc. (Baldwin, MD) from 2006 to 2024: 10 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 13 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Greiner Bio-One North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 12010: 22012: 22013: 12024: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2011: 12012: 12020: 12024: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Greiner Bio-One North America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen5decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection5decisions

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061483Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 20063cite it
  • K121908Safety Infusion SetGreiner Bio-One North America, Inc. · 20122cite it
  • K122687Blood Culture HolderGreiner Bio-One North America, Inc. · 20132cite it
  • K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 20071cites it
  • K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 20101cites it
  • K113505Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc. · 20121cites it

What has FDA decided for it lately?

  • K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
  • K122687Blood Culture HolderGreiner Bio-One North America, Inc. · 2013
  • K121908Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
  • K113505Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc. · 2012
  • K103041Vacuette Blood Collection Tube with Lithium Heparin and Gel SeparatorGreiner Bio-One North America, Inc. · 2010
  • K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. · 20101 recall
  • K081929Vacuette Blood Collection Tube with Clot Activator and Gel SeparatorGreiner Bio-One North America, Inc. · 20083 recalls
  • K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 20071 recall

All 10 as Greiner Bio-One North America, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K081929Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog…Aug 19, 2025Class II
  • K081929VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring…May 14, 2024Class II
  • K081929VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product…Aug 28, 2020Class II
  • K072320Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick…Apr 2, 2012Class II
  • K102774Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with…Aug 11, 2011

Other applicant names beginning “Greiner”

FDA records each applicant name separately; these may or may not be the same firm.

Greiner Meditech, Inc. 10Greiner America, Inc. 7Greiner Vacuette North America, Inc. 5Greiner Bio-One Vacuette North America 5Greiner Bio-One Na, Inc. 5