510(k) Report

FDA applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Franklin Lakes, NJ634 decisions1976–2001106 recalls

FDA records 634 decisions for Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, NJ) from 1976 to 2001: 632 510(k) clearances and 2 original PMA approvals. Most are in product codes JTN (Susceptibility Test Discs, Antimicrobial) and JWY (Manual Antimicrobial Susceptibility Test Systems). Its devices cite 11 predicates, 4 of them its own earlier devices. 106 recalls are linked to its devices, 1 Class I.

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

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

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

FDA decisions per year

No FDA decision for Bd Becton Dickinson Vacutainer Systems Preanalytic since 2007.

Recalls per year

1in 2026

2007: 82009: 52011: 12012: 22013: 92014: 52015: 22016: 22017: 42018: 22019: 192020: 22024: 222025: 3, 1 Class I2026 (partial year): 1
2007high 22 (2024) · low 0 (2008)2026

Class I Class II/III not classified

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

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