# Greiner Bio-One Na, Inc.

- Location (FDA's records): Monroe, NC
- FDA decisions: 5 (2016–2019): 5 510(k) clearances
- Product codes: FMI (3), JSM (1), JKA (1)
- 510(k) review time since 2016: median 153 days, against 179 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Greiner Bio-One North America, Inc.: 1 (https://510kreport.com/company/greiner-bio-one-north-america)
- Bd: 1 (https://510kreport.com/company/bd)
- Greiner Meditech, Inc.: 1 (https://510kreport.com/company/greiner-meditech)
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.: 1 (https://510kreport.com/company/anhui-hongyu-wuzhou-medical-manufacturer)

## Its most-cited devices
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (2018), cited by 1
- K160532: Greiner Holdex (2016), cited by 1

## Recent decisions
- K182078: MiniCollect K2E K2EDTA Tubes (Jan 25, 2019)
- K180545: VACUETTE SAFELINK Holder with male luer lock (May 21, 2018)
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (Apr 19, 2018)
- K163436: Greiner Vacuette Urine Count and Culture, Mannitol tube (Mar 6, 2017)
- K160532: Greiner Holdex (Nov 3, 2016)

Source page: https://510kreport.com/company/greiner-bio-one-na