510(k) Report

FDA applicant

Becton, Dickinson and Company (BD)

Franklin Lakes, NJ5 decisions2009–20261 recall

FDA records 5 decisions for Becton, Dickinson and Company (BD) (Franklin Lakes, NJ) from 2009 to 2026: 5 510(k) clearances. Most are in product codes FQH (Lavage, Jet) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Becton, Dickinson and Company (BD)’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2009: 12011: 32026 (partial year): 1
2009high 3 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2009high 1 (2024) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Becton, Dickinson and Company (BD) by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FQHLavage, Jet1decision
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • JTNSusceptibility Test Discs, Antimicrobial1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 20111cites it

What has FDA decided for it lately?

  • K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
  • K112586Ceftaroline 30 Micrograms, BBL (TM) Sensi-Disc (TM)Becton, Dickinson and Company (BD) · 20111 recall
  • K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
  • K110105BD Pen NeedleBecton, Dickinson and Company (BD) · 2011
  • K091292BD Vacutainer Rapid Serum Tube Plus Blood Collection Tube, Model 368771Becton, Dickinson and Company (BD) · 2009

All 5 as Becton, Dickinson and Company (BD) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K112586BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro…Jan 8, 2024Class 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 Vacutainer Systems 15Becton Dickinson Diagnostic Instrument Systems 13Becton Dickinson Advanced Diagnostics 10Becton Dickinson Labware 3Becton Dickinson Consumer Products 3Becton Dickinson Biosciences 1Becton, Dickinson and Company (Bard Access Systems… 1