# Greiner Bio-One Vacuette North America

- Location (FDA's records): Baldwin, MD
- FDA decisions: 5 (2001–2008): 5 510(k) clearances
- Product codes: FMI (2), JKA (2), PJE (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton Dickinson Vacutainer Systems: 2 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)
- Greiner Vacuette North America, Inc.: 1 (https://510kreport.com/company/greiner-vacuette-north-america)
- Greiner America, Inc.: 1 (https://510kreport.com/company/greiner-america)

## Firms that cite its devices most
- Greiner Bio-One North America, Inc.: 3 (https://510kreport.com/company/greiner-bio-one-north-america)

## Its most-cited devices
- K033478: Vacuette Quickshield Safety Tube Holder (2003), cited by 2
- K080235: Safety Infusion Set (2008), cited by 1

## Recent decisions
- K080235: Safety Infusion Set (Apr 24, 2008)
- K042927: Vacuette Edta K3 Evacuated Blood Collection Tubes (Apr 15, 2005)
- K033478: Vacuette Quickshield Safety Tube Holder (Dec 29, 2003)
- K023971: Vacuette Trace Elements Tubes (Jan 27, 2003)
- K011699: Vacuette Evacuated Blood Collection Tubes (Jun 28, 2001)

Source page: https://510kreport.com/company/greiner-bio-one-vacuette-north-america