510(k) Report

FDA applicant

Becton Dickinson Vacutainer Systems

Franklin Lake, NJ15 decisions1995–200028 recalls

FDA records 15 decisions for Becton Dickinson Vacutainer Systems (Franklin Lake, NJ) from 1995 to 2000: 15 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and GIM (Tubes, Vacuum Sample, With Anticoagulant). Its devices cite 10 predicates, 1 of them its own earlier devices. 28 recalls are linked to its devices, 3 Class I.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Becton Dickinson Vacutainer Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Becton Dickinson Vacutainer Systems since 2007.

Recalls per year

2in 2022

2007: 12014: 32015: 62018: 3, 3 Class I2019: 92022: 2
2007high 9 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Becton Dickinson Vacutainer Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Becton Dickinson Vacutainer Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection11decisions
  • GIMTubes, Vacuum Sample, With Anticoagulant2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision
  • PJEBlood/Plasma Collection Device For Dna Testing1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 1 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.

  • K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems · 19988cite it
  • K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety…Becton Dickinson Vacutainer Systems · 19996cite it
  • K972075Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 19985cite it
  • K981013Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum TubeBecton Dickinson Vacutainer Systems · 19982cite it
  • K960250Vacutainer Brand Plus Serum & SST TubesBecton Dickinson Vacutainer Systems · 19962cite it
  • K954592Vacutainer Brand PST Plasma Separation TubeBecton Dickinson Vacutainer Systems · 19951cites it

What has FDA decided for it lately?

  • K002456Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992Becton Dickinson Vacutainer Systems · 200010 recalls
  • K991702Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578Becton Dickinson Vacutainer Systems · 19999 recalls
  • K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety…Becton Dickinson Vacutainer Systems · 19994 recalls
  • K991120Vacutainer Brand Ctad Tube (Multiple)Becton Dickinson Vacutainer Systems · 1999
  • K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems · 19981 recall
  • K982922Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998
  • K981013Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum TubeBecton Dickinson Vacutainer Systems · 19982 Class I recalls
  • K972075Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998

All 15 as Becton Dickinson Vacutainer Systems →

What has been recalled?

28 recalls linked to its devices; the latest:

  • K991088Regard Custom Procedure Kits containing BD Luer Lok Access DevicesFeb 24, 2022Class III
  • K991088BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed…Jan 6, 2022Class III
  • K991702BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965May 13, 2019Class II
  • K991702BD Microtainer SST- Amber Part/Catalog Number: 365978May 13, 2019Class II
  • K991702BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985May 13, 2019Class II
  • K991702BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963May 13, 2019Class II

Other applicant names beginning “Becton”

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

Becton, Dickinson & CO 342Becton Dickinson Infusion Therapy Systems, Inc. 36Becton Dickinson Microbiology Systems 33Becton Dickinson Vascular Access, Inc. 25Becton Dickinson Immunocytometry Systems 21Becton Dickinson Diagnostic Instrument Systems 13Becton Dickinson Advanced Diagnostics 10Becton, Dickinson and Company (BD) 5Becton Dickinson Labware 3Becton Dickinson Consumer Products 3Becton Dickinson Biosciences 1Becton, Dickinson and Company (Bard Access Systems… 1