# Becton Dickinson Vacutainer Systems

- Location (FDA's records): Franklin Lake, NJ
- FDA decisions: 15 (1995–2000): 15 510(k) clearances
- Product codes: JKA (11), GIM (2), FMI (1), PJE (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 28 (1 its own)
- Recalls linked to its devices: 28 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 5 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Radiometer America, Inc.: 1 (https://510kreport.com/company/radiometer-america)
- Ciba Corning Diagnostics Corp.: 1 (https://510kreport.com/company/ciba-corning-diagnostics)
- Bio-Plexus, Inc.: 1 (https://510kreport.com/company/bio-plexus)

## Firms that cite its devices most
- Becton, Dickinson & CO: 9 (https://510kreport.com/company/becton-dickinson)
- Greiner Vacuette North America, Inc.: 2 (https://510kreport.com/company/greiner-vacuette-north-america)
- Nsp Tech Pte, Ltd.: 2 (https://510kreport.com/company/nsp-tech)
- Greiner Bio-One Vacuette North America: 2 (https://510kreport.com/company/greiner-bio-one-vacuette-north-america)
- Bd Vacutainer Systems Preanalyical Solutions: 1 (https://510kreport.com/company/bd-vacutainer-systems-preanalyical-solutions)
- Kawasumi Laboratories Co., Ltd.: 1 (https://510kreport.com/company/kawasumi-laboratories)
- Owen Mumford, Ltd.: 1 (https://510kreport.com/company/owen-mumford)
- Preanalytix GmbH: 1 (https://510kreport.com/company/preanalytix)

## Its most-cited devices
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 (1998), cited by 8
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle (1999), cited by 6
- K972075: Vacutainer Brand PPT Plasma Preparation Tube (1998), cited by 5
- K981013: Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube (1998), cited by 2
- K960250: Vacutainer Brand Plus Serum & SST Tubes (1996), cited by 2
- K954592: Vacutainer Brand PST Plasma Separation Tube (1995), cited by 1

## Recent decisions
- K002456: Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992 (Nov 2, 2000)
- K991702: Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578 (Jul 28, 1999)
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle (May 28, 1999)
- K991120: Vacutainer Brand Ctad Tube (Multiple) (May 19, 1999)
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 (Oct 28, 1998)
- K982922: Vacutainer Brand Blood Collection Syringe (Sep 22, 1998)
- K981013: Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube (Jun 17, 1998)
- K972075: Vacutainer Brand PPT Plasma Preparation Tube (Feb 24, 1998)

Source page: https://510kreport.com/company/becton-dickinson-vacutainer-systems