# Bd Becton Dickinson Vacutainer Systems Preanalytic

- Location (FDA's records): Franklin Lakes, NJ
- FDA decisions: 634 (1976–2001): 632 510(k) clearances and 2 original PMA approvals
- Product codes: JTN (43), JWY (32), FMF (23), FMI (20), JSJ (16), GKZ (15), FRN (14), JKA (13), LYZ (13), GKL (11), FOZ (10), JSH (10)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 206 (4 its own)
- Recalls linked to its devices: 106 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dms Laboratories: 2 (https://510kreport.com/company/dms-laboratories)
- Sherwood Medical Co.: 1 (https://510kreport.com/company/sherwood-medical)
- Mcgaw, Inc.: 1 (https://510kreport.com/company/mcgaw)
- Becton Dickinson Vascular Access, Inc.: 1 (https://510kreport.com/company/becton-dickinson-vascular-access)
- Vitek Systems, Inc.: 1 (https://510kreport.com/company/vitek-systems)
- Ulster Scientific, Inc.: 1 (https://510kreport.com/company/ulster-scientific)

## Firms that cite its devices most
- Becton, Dickinson & CO: 36 (https://510kreport.com/company/becton-dickinson)
- Bd: 9 (https://510kreport.com/company/bd)
- B.Braun Medical, Inc.: 7 (https://510kreport.com/company/b-braun-medical)
- Becton Dickinson Immunocytometry Systems: 6 (https://510kreport.com/company/becton-dickinson-immunocytometry-systems)
- Becton Dickinson Vacutainer Systems: 5 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)
- Maxxim Medical: 4 (https://510kreport.com/company/maxxim-medical)
- Disetronic Medical Systems: 4 (https://510kreport.com/company/disetronic-medical-systems)
- Greiner Meditech, Inc.: 3 (https://510kreport.com/company/greiner-meditech)

## Its most-cited devices
- K980987: Becton Dickinson Syringe (1998), cited by 18
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set (1998), cited by 12
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe (1996), cited by 10
- K980580: Becton Dickinson Syringes (1998), cited by 9
- K951254: Safetyglide Needle (1995), cited by 8
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe (1994), cited by 8

## Recent decisions
- K003062: Bactec Mgit 960 Sir Kits (Jun 6, 2001)
- K003553: 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush Syringe (Mar 21, 2001)
- K003461: BD Vacutainer Passive Shielding Blood Collection Needle (Feb 1, 2001)
- K002938: B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 (Nov 29, 2000)
- K001364: BD Directigen Flu a+B (Jun 28, 2000)
- K000762: Moxifloxacin, 5 UG, BBL Sensi-Disc (Apr 25, 2000)
- K000829: Gatifloxacin, 5 UG, BBL Sensi-Disc (Apr 13, 2000)
- K993186: Synercid, 15 UG, BBL Sensi-Disc (Nov 3, 1999)

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