510(k) Report

FDA applicant

Bd Biosciences

San Jose, CA11 decisions2000–20268 recalls

FDA records 11 decisions for Bd Biosciences (San Jose, CA) from 2000 to 2026: 11 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and OYE (Flow Cytometric Reagents And Accessories.). Its devices cite 12 predicates, 6 of them its own earlier devices. 8 recalls are linked to its devices.

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

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Bd Biosciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 22008: 12009: 12015: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2022

2007: 22009: 12015: 12016: 12022: 3
2007high 3 (2022) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Bd Biosciences’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?

  • GKZCounter, Differential Cell9decisions
  • OYEFlow Cytometric Reagents And Accessories.2decisions

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K041074BD Facscanto with BD Facsanto SoftwareBd Biosciences · 20043cite it
  • K071141BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Bd Biosciences · 20072cite it
  • K071143BD Tritest CD3/CD4/CD45, Model 340383Bd Biosciences · 20071cites it
  • K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 20061cites it
  • K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 20091cites it
  • K000897Calibrite Percp-CY5.5 Beads and Facscomp SoftwareBd Biosciences · 20001cites it

What has FDA decided for it lately?

  • K260215BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3]…Bd Biosciences · 2026
  • K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3…Bd Biosciences · 2015
  • K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 20093 recalls
  • K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 20082 recalls
  • K071143BD Tritest CD3/CD4/CD45, Model 340383Bd Biosciences · 20071 recall
  • K071141BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Bd Biosciences · 2007
  • K062087BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962Bd Biosciences · 20063 recalls
  • K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006

All 11 as Bd Biosciences →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K090967BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes…Oct 3, 2022Class II
  • K090967BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use…Oct 3, 2022Class II
  • K090967BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes…Oct 3, 2022Class II
  • K071143BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states…Jul 18, 2016Class III
  • K040725BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto…Jun 15, 2015Class III
  • K081213BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number…Jan 29, 2009